FDA enforcement deep dive

Boston Scientific Corporation: FDA Enforcement History

Name: FDA Enforcement Actions Against Boston Scientific Corporation
Creator: Argus HQ
License: https://argushq.ai/methodology

Most recent tracked FDA action: July 8, 2026

Boston Scientific Corporation has 272 device recalls tracked in the Argus HQ database, most severely the March-May 2026 ACCOLADE and cardiac resynchronization pacemaker recall tied to a software/battery Safety Mode defect -- Boston Scientific itself reported 4 deaths and 2,557 serious injuries associated with that issue as of the FDA’s May 8, 2026 advisory. The tables below break the full tracked history down by severity, month, and recurring recall-reason category, each row linked to its FDA.gov source.

FDA action counts (Argus HQ database)

Total tracked FDA actions	272
Recalls	272
Warning letters	0
Form 483 inspection citations	0
Most recent tracked action	July 8, 2026
Most severe rating on file	critical

Recall severity breakdown

Computed from all 272 tracked recalls. FDA classifies each recall Class I (most serious), II, or III on the underlying record; Argus HQ maps that to critical/high/medium/low severity buckets.

high	159 (58.5%)
critical	113 (41.5%)

Recall velocity by month

Months with at least one tracked recall for Boston Scientific Corporation, oldest to most recent. Gaps indicate months with zero tracked recalls, not missing data.

Month	Recalls
2023-03	1
2023-04	1
2023-05	2
2023-08	9
2023-10	16
2023-11	2
2024-01	1
2024-02	1
2024-04	9
2024-05	48
2024-07	1
2024-08	2
2024-09	5
2024-10	54
2024-11	7
2024-12	2
2025-01	6
2025-02	14
2025-05	4
2025-07	4
2025-08	5
2025-09	17
2025-10	35
2026-01	1
2026-02	6
2026-03	1
2026-05	4
2026-06	1
2026-07	13

Recurring recall-reason patterns

Argus HQ keyword-matched the free-text “reason for recall” field on each tracked record into categories below. FDA does not publish a structured reason code for device recalls, so this is Argus HQ’s own pattern analysis, not an official FDA classification — records that don’t match a listed keyword fall into “Other.”

Other / not pattern-matched	171 recalls
Software	52 recalls
Battery	33 recalls
Sterility	23 recalls
Labeling	20 recalls
Packaging	15 recalls

Full recall history (272)

Most recent first. Every row links to its Argus HQ record and FDA.gov source.

Date	Severity	Title
2026-07-08	high	Boston Scientific Corporation — Class II recall: CRE Pro Wireguided 8-10mm 240cm
2026-07-08	high	Boston Scientific Corporation — Class II recall: CRE Wireguided 15-18mm 240cm
2026-07-08	high	Boston Scientific Corporation — Class II recall: CRE Wireguided 10-12mm 240cm
2026-07-08	high	Boston Scientific Corporation — Class II recall: CRE Pro Wireguided 6-8mm 240cm
2026-07-08	high	Boston Scientific Corporation — Class II recall: CRE Wireguided 6-8mm 240cm
2026-07-08	high	Boston Scientific Corporation — Class II recall: CRE Wireguided 18-20mm 240cm
2026-07-08	high	Boston Scientific Corporation — Class II recall: CRE Pro Wireguided 15-18mm 240cm
2026-07-08	high	Boston Scientific Corporation — Class II recall: CRE Pro Wireguided 12-15mm 240cm
2026-07-08	high	Boston Scientific Corporation — Class II recall: CRE Pro Wireguided 18-20mm 240cm
2026-07-08	high	Boston Scientific Corporation — Class II recall: CRE Pro Wireguided 10-12mm 240cm
2026-07-08	high	Boston Scientific Corporation — Class II recall: CRE Wireguided 12-15mm 240cm
2026-07-08	high	Boston Scientific Corporation — Class II recall: CRE Wireguided 8-10mm 240cm
2026-07-01	high	Boston Scientific Corporation — Class II recall: Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable…
2026-06-17	high	Boston Scientific Corporation — Class II recall: Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50;…
2026-05-13	high	Boston Scientific Corporation — Class II recall: LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUD…
2026-05-13	high	Boston Scientific Corporation — Class II recall: LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRA…
2026-05-06	critical	Boston Scientific Corporation — Class I recall: Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardia…
2026-05-06	critical	Boston Scientific Corporation — Class I recall: Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALIT…
2026-03-18	high	Boston Scientific Corporation — Class II recall: EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box…
2026-02-11	critical	Boston Scientific Corporation — Class I recall: HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Materi…
2026-02-11	critical	Boston Scientific Corporation — Class I recall: AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material N…
2026-02-11	critical	Boston Scientific Corporation — Class I recall: *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Mater…
2026-02-11	critical	Boston Scientific Corporation — Class I recall: AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material…
2026-02-11	critical	Boston Scientific Corporation — Class I recall: AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Material N…
2026-02-11	critical	Boston Scientific Corporation — Class I recall: *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Mat…
2026-01-21	high	Boston Scientific Corporation — Class II recall: Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1) 2…
2025-10-22	critical	Boston Scientific Corporation — Class I recall: Model Number U226, VISIONIST CRT-P EL
2025-10-22	critical	Boston Scientific Corporation — Class I recall: Model Number L209 PROPONENT DR (VDD) SL Pacemaker
2025-10-22	critical	Boston Scientific Corporation — Class I recall: Model Number S702, ALTRUA 2 DR SL Pacemaker
2025-10-22	critical	Boston Scientific Corporation — Class I recall: Model Number L131, ESSENTIO DR EL MRI Pacemaker
2025-10-22	critical	Boston Scientific Corporation — Class I recall: Model Number L221 PROPONENT DR EL Pacemaker
2025-10-22	critical	Boston Scientific Corporation — Class I recall: Model Number L111, ESSENTIO DR SL MRI Pacemaker
2025-10-22	critical	Boston Scientific Corporation — Class I recall: Model Number U125, VALITUDE CRT-P EL
2025-10-22	critical	Boston Scientific Corporation — Class I recall: ACCOLADE SR SL (Model L300)
2025-10-22	critical	Boston Scientific Corporation — Class I recall: ACCOLADE SR SL MRI (Model L310)
2025-10-22	critical	Boston Scientific Corporation — Class I recall: Model Number L211 PROPONENT DR SL MRI Pacemaker
2025-10-22	high	Boston Scientific Corporation — Class II recall: TENACIO Pump with InhibiZone; UPN: 72404429;
2025-10-22	critical	Boston Scientific Corporation — Class I recall: PROPONENT SR SL (Model L200)
2025-10-22	critical	Boston Scientific Corporation — Class I recall: Model Number S722, ALTRUA 2 DR EL Pacemaker
2025-10-22	critical	Boston Scientific Corporation — Class I recall: Model Number L110, ESSENTIO SR SL MRI Pacemaker
2025-10-22	critical	Boston Scientific Corporation — Class I recall: ACCOLADE DR SL MRI (Model L311)
2025-10-22	critical	Boston Scientific Corporation — Class I recall: Model Number L210 PROPONENT SR SL Pacemaker
2025-10-22	critical	Boston Scientific Corporation — Class I recall: Model Number L101, ESSENTIO DR SL Pacemaker
2025-10-22	high	Boston Scientific Corporation — Class II recall: TENACIO Pump without InhibiZone; UPN: 72404420;
2025-10-22	critical	Boston Scientific Corporation — Class I recall: ACCOLADE DR SL (Model L301)
2025-10-22	critical	Boston Scientific Corporation — Class I recall: ACCOLADE DR EL MRI (Model L331)
2025-10-22	high	Boston Scientific Corporation — Class II recall: CXR Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404461 (12CM…
2025-10-22	critical	Boston Scientific Corporation — Class I recall: PROPONENT DR SL (Model L201)
2025-10-22	high	Boston Scientific Corporation — Class II recall: LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12CM I…
2025-10-22	high	Boston Scientific Corporation — Class II recall: CX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404430 (12CM…
2025-10-22	critical	Boston Scientific Corporation — Class I recall: Model Number U228, VISIONIST CRT-P EL MRI
2025-10-22	critical	Boston Scientific Corporation — Class I recall: Model Number L231, PROPONENT DR EL MRI Pacemaker
2025-10-22	critical	Boston Scientific Corporation — Class I recall: ACCOLADE DR EL (Model L321)
2025-10-22	critical	Boston Scientific Corporation — Class I recall: Model Number U225 VISIONIST CRT-P EL
2025-10-22	high	Boston Scientific Corporation — Class II recall: LGX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404450 (12CM…
2025-10-22	critical	Boston Scientific Corporation — Class I recall: Model Number L121 ESSENTIO DR EL Pacemaker
2025-10-22	critical	Boston Scientific Corporation — Class I recall: Model Number U128, VALITUDE CRT-P EL MRI
2025-10-22	high	Boston Scientific Corporation — Class II recall: CX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404486 (15CM IP…
2025-10-22	critical	Boston Scientific Corporation — Class I recall: Model Number L100, ESSENTIO SR SL Pacemaker
2025-10-22	critical	Boston Scientific Corporation — Class I recall: Model Number S701 ALTRUA 2 SR SL Pacemaker
2025-10-01	high	Boston Scientific Corporation — Class II recall: Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm B…
2025-09-17	high	Boston Scientific Corporation — Class II recall: Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000
2025-09-17	high	Boston Scientific Corporation — Class II recall: Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN): 1. H749…
2025-09-17	high	Boston Scientific Corporation — Class II recall: Boston Scientific UroMax Ultra Kit, Material Numbers (UPN): 1. M0062251200,…
2025-09-17	high	Boston Scientific Corporation — Class II recall: Boston Scientific Encore Advantage Kit, Material Numbers (UPN): 1. H749045270…
2025-09-17	high	Boston Scientific Corporation — Class II recall: Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; 2…
2025-09-17	high	Boston Scientific Corporation — Class II recall: ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Mater…
2025-09-10	critical	Boston Scientific Corporation — Class I recall: WATCHMAN TruSeal Access System DBL, US, Material Number (UPN) M635TU70020; inten…
2025-09-10	critical	Boston Scientific Corporation — Class I recall: WATCHMAN TruSeal Access System DBL, OUS, Material Number (UPN) M635TS70020; inte…
2025-09-10	critical	Boston Scientific Corporation — Class I recall: WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; inten…
2025-09-10	critical	Boston Scientific Corporation — Class I recall: WATCHMAN FXD Curve Access Sys Sgl, OUS, Material Number (UPN) M635TS80010; inten…
2025-09-10	critical	Boston Scientific Corporation — Class I recall: WATCHMAN TruSteer Access System, US, Material Number (UPN) M635TU90050;intended…
2025-09-10	critical	Boston Scientific Corporation — Class I recall: WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020; int…
2025-09-10	critical	Boston Scientific Corporation — Class I recall: WATCHMAN FXD Curve Access System Sgl, US, Material Number (UPN) M635TU80010; int…
2025-09-10	critical	Boston Scientific Corporation — Class I recall: WATCHMAN TruSeal Access System SGL, OUS, Material Number (UPN) M635TS70010; inte…
2025-09-10	critical	Boston Scientific Corporation — Class I recall: WATCHMAN FXD Curve Access Sys Dbl, OUS, Material Number (UPN) M635TS80020; inten…
2025-09-10	critical	Boston Scientific Corporation — Class I recall: WATCHMAN TruSeal Access System ANT, OUS, Material Number (UPN) M635TS70040; inte…
2025-09-10	critical	Boston Scientific Corporation — Class I recall: WATCHMAN TruSeal Access System ANT, US, Material Number (UPN) M635TU70040; inten…
2025-08-27	critical	Boston Scientific Corporation — Class I recall: RELIANCE 4-FRONT, endocardial cardioversion/defibrillation and pace/sense lead,…
2025-08-27	critical	Boston Scientific Corporation — Class I recall: ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead, Pe…
2025-08-27	critical	Boston Scientific Corporation — Class I recall: ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardioverter…
2025-08-20	high	Boston Scientific Corporation — Class II recall: FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
2025-08-20	critical	Boston Scientific Corporation — Class I recall: Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent, sten…
2025-07-16	high	Boston Scientific Corporation — Class II recall: VersaCross Access Solution (VXSK), Product Description and ID: VXSK (180J RF…
2025-07-16	high	Boston Scientific Corporation — Class II recall: Torflex Transseptal Guiding Sheath Kit (TFK-M) TF85-32-63-45 TORFLEX 8.5F 63…
2025-07-16	high	Boston Scientific Corporation — Class II recall: VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VXS 6…
2025-07-16	high	Boston Scientific Corporation — Class II recall: VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in t…
2025-05-07	high	Boston Scientific Corporation — Class II recall: IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100. The needle…
2025-05-07	high	Boston Scientific Corporation — Class II recall: IceSeed 1.5 CX NEEDLE OUS, Cryoablation Needle, REF H7493967534170. The needles…
2025-05-07	high	Boston Scientific Corporation — Class II recall: IceSeed 1.5 CX S NEEDLE OUS, Cryoablation Needle, REF H7493967334100. The needl…
2025-05-07	high	Boston Scientific Corporation — Class II recall: IceSeed 1.5 CX NEEDLE US, Cryoablation Needle, REF H7493967433170. The needles…
2025-02-05	high	Boston Scientific Corporation — Class II recall: AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M005536…
2025-02-05	high	Boston Scientific Corporation — Class II recall: AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553680
2025-02-05	high	Boston Scientific Corporation — Class II recall: AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M005536…
2025-02-05	high	Boston Scientific Corporation — Class II recall: HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00…
2025-02-05	high	Boston Scientific Corporation — Class II recall: AXIOS Stent and Delivery System 15mmx10mm UPN: M00553750
2025-02-05	high	Boston Scientific Corporation — Class II recall: HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M0055…
2025-02-05	high	Boston Scientific Corporation — Class II recall: AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M005…
2025-02-05	high	Boston Scientific Corporation — Class II recall: AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M005536…
2025-02-05	high	Boston Scientific Corporation — Class II recall: AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553690
2025-02-05	high	Boston Scientific Corporation — Class II recall: HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00…
2025-02-05	high	Boston Scientific Corporation — Class II recall: HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00…
2025-02-05	high	Boston Scientific Corporation — Class II recall: HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00…
2025-02-05	high	Boston Scientific Corporation — Class II recall: AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740
2025-02-05	high	Boston Scientific Corporation — Class II recall: HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M0055…
2025-01-22	critical	Boston Scientific Corporation — Class I recall: ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (M…
2025-01-22	critical	Boston Scientific Corporation — Class I recall: ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722)
2025-01-22	critical	Boston Scientific Corporation — Class I recall: VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)
2025-01-22	critical	Boston Scientific Corporation — Class I recall: PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL…
2025-01-22	critical	Boston Scientific Corporation — Class I recall: VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228)
2025-01-22	critical	Boston Scientific Corporation — Class I recall: ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Mo…
2024-12-04	high	Boston Scientific Corporation — Class II recall: AMS Artificial Urinary Sphincter Control Pump
2024-12-04	high	Boston Scientific Corporation — Class II recall: AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O
2024-11-20	critical	Boston Scientific Corporation — Class I recall: Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS216…
2024-11-20	critical	Boston Scientific Corporation — Class I recall: Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2…
2024-11-20	critical	Boston Scientific Corporation — Class I recall: Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2…
2024-11-20	critical	Boston Scientific Corporation — Class I recall: Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS21…
2024-11-20	critical	Boston Scientific Corporation — Class I recall: Boston Scientific POLARx FIT BALLOON CATHETER ST OUS, Material Number M004CRBS2…
2024-11-20	critical	Boston Scientific Corporation — Class I recall: Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS206…
2024-11-20	critical	Boston Scientific Corporation — Class I recall: Boston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number M004CRB…
2024-10-30	high	Boston Scientific Corporation — Class II recall: Boston Scientific myLUX Patient Application for an Apple Mobile device, Model N…
2024-10-23	high	Boston Scientific Corporation — Class II recall: Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MO…
2024-10-23	high	Boston Scientific Corporation — Class II recall: Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EU…
2024-10-23	high	Boston Scientific Corporation — Class II recall: Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM -…
2024-10-23	high	Boston Scientific Corporation — Class II recall: Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM -…
2024-10-23	high	Boston Scientific Corporation — Class II recall: Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM JA…
2024-10-23	high	Boston Scientific Corporation — Class II recall: Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM JA…
2024-10-23	high	Boston Scientific Corporation — Class II recall: Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO +…
2024-10-23	high	Boston Scientific Corporation — Class II recall: Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MO…
2024-10-23	high	Boston Scientific Corporation — Class II recall: Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO IN…
2024-10-23	high	Boston Scientific Corporation — Class II recall: Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM -…
2024-10-23	high	Boston Scientific Corporation — Class II recall: Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EV…
2024-10-23	high	Boston Scientific Corporation — Class II recall: Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM US…
2024-10-23	high	Boston Scientific Corporation — Class II recall: Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM -…
2024-10-23	high	Boston Scientific Corporation — Class II recall: Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO IN…
2024-10-23	high	Boston Scientific Corporation — Class II recall: Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM US…
2024-10-23	high	Boston Scientific Corporation — Class II recall: Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO +…
2024-10-23	high	Boston Scientific Corporation — Class II recall: Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM EU…
2024-10-23	high	Boston Scientific Corporation — Class II recall: Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EV…
2024-10-23	high	Boston Scientific Corporation — Class II recall: Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM -…
2024-10-23	high	Boston Scientific Corporation — Class II recall: Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EV…
2024-10-23	high	Boston Scientific Corporation — Class II recall: Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO+ BRIDGE TO INTE…
2024-10-23	high	Boston Scientific Corporation — Class II recall: Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MO…
2024-10-02	high	Boston Scientific Corporation — Class II recall: WALLFLEX ESOPHAGEAL FC 18/23-25MMX10CM- Wallflex Esophageal Partially Covered (P…
2024-10-02	high	Boston Scientific Corporation — Class II recall: AGILE ESO OTW PC 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (PC)…
2024-10-02	high	Boston Scientific Corporation — Class II recall: WALLFLEX PC ESOPH STENT 18/23MM X 103MM- Wallflex Esophageal Partially Covered a…
2024-10-02	high	Boston Scientific Corporation — Class II recall: WALLFLEX ESOPHAGEAL FC 18/23-25MMX15CM- Agile Esophageal Partially Covered and F…
2024-10-02	high	Boston Scientific Corporation — Class II recall: AGILE ESO FC RMV 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (PC)…
2024-10-02	high	Boston Scientific Corporation — Class II recall: AGILE ESO FC RMV 23MM X 6.2CM IN 18.5 FR-Agile Esophageal Partially Covered (PC)…
2024-10-02	high	Boston Scientific Corporation — Class II recall: AGILE ESO OTW PC 23MM X 15.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC)…
2024-10-02	high	Boston Scientific Corporation — Class II recall: WALLFLEX PC ESOPH STENT 23/28MM X 155MM- Wallflex Esophageal Partially Covered a…
2024-10-02	high	Boston Scientific Corporation — Class II recall: WALLFLEX FC ESO STENT RMV 23X105MM- Wallflex Esophageal Partially Covered (PC) a…
2024-10-02	high	Boston Scientific Corporation — Class II recall: WALLFLEX PC ESOPH STENT 23/28MM X 105MM- Wallflex Esophageal Partially Covered a…
2024-10-02	high	Boston Scientific Corporation — Class II recall: WALLFLEX FC ESO STENT RMV LL 23X105- Intended for maintaining esophageal luminal…
2024-10-02	high	Boston Scientific Corporation — Class II recall: WALLFLEX FC ESO STENT RMV 18X103MM- Wallflex Esophageal Partially Covered (PC) a…
2024-10-02	high	Boston Scientific Corporation — Class II recall: WALLFLEX FC ESO STENT RMV LL 23X125-Wallflex Esophageal Partially Covered (PC) a…
2024-10-02	high	Boston Scientific Corporation — Class II recall: WALLFLEX ESOPHAGEAL FC 23/28MMX12CM- Wallflex Esophageal Partially Covered and F…
2024-10-02	high	Boston Scientific Corporation — Class II recall: WALLFLEX FC ESO STENT RMV 23X155MM- Wallflex Esophageal Partially Covered (PC) a…
2024-10-02	high	Boston Scientific Corporation — Class II recall: WALLFLEX ESOPHAGEAL FC 23/28MMX15CM-Wallflex Esophageal Partially Covered and Fu…
2024-10-02	high	Boston Scientific Corporation — Class II recall: WALLFLEX PC ESOPH STENT 18/23MM X 123MM- Wallflex Esophageal Partially Covered a…
2024-10-02	high	Boston Scientific Corporation — Class II recall: WALLFLEX PC ESOPH STENT 23/28MM X 125MM- Wallflex Esophageal Partially Covered a…
2024-10-02	high	Boston Scientific Corporation — Class II recall: WALLFLEX ESOPHAGEAL FC 18/23-25MMX12CM-- Wallflex Esophageal Partially Covered (…
2024-10-02	high	Boston Scientific Corporation — Class II recall: AGILE ESO OTW PC 23MM X 12.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC)…
2024-10-02	high	Boston Scientific Corporation — Class II recall: AGILE ESO OTW FC 23MM X 15.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC)…
2024-10-02	high	Boston Scientific Corporation — Class II recall: WALLFLEX ESOPHAGEAL FC 23/28MMX10CM- Wallflex Esophageal Partially Covered and F…
2024-10-02	high	Boston Scientific Corporation — Class II recall: WALLFLEX FC ESO STENT RMV 18X153MM-Wallflex Esophageal Partially Covered (PC) an…
2024-10-02	high	Boston Scientific Corporation — Class II recall: AGILE ESO OTW PC 23MM X 6.2CM IN 18.5 FR- Agile Esophageal Partially Covered (P…
2024-10-02	high	Boston Scientific Corporation — Class II recall: WALLFLEX FC ESO STENT RMV LL 23X155- Wallflex Esophageal Partially Covered (PC)…
2024-10-02	high	Boston Scientific Corporation — Class II recall: WALLFLEX FC ESO STENT RMV 23X125MM- Wallflex Esophageal Partially Covered (PC) a…
2024-10-02	high	Boston Scientific Corporation — Class II recall: WALLFLEX PC ESOPH STENT 18/23MM X 153MM- Wallflex Esophageal Partially Covered a…
2024-10-02	high	Boston Scientific Corporation — Class II recall: AGILE ESO OTW FC 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (PC)…
2024-10-02	high	Boston Scientific Corporation — Class II recall: WALLFLEX FC ESO STENT RMV LL 18X103- Wallflex Esophageal Partially Covered (PC)…
2024-10-02	high	Boston Scientific Corporation — Class II recall: WALLFLEX FC ESO STENT RMV 18X123MM-Wallflex Esophageal Partially Covered (PC) an…
2024-10-02	high	Boston Scientific Corporation — Class II recall: AGILE ESO FC RMV 23MM X 15.0CM IN 18.5 F- Agile Esophageal Partially Covered (P…
2024-09-25	high	Boston Scientific Corporation — Class II recall: vanSonnenberg Sump Locking Pigtail Regular Kit Sump Catheter System Kit, Materia…
2024-09-25	high	Boston Scientific Corporation — Class II recall: Flexima APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001271…
2024-09-25	high	Boston Scientific Corporation — Class II recall: VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300;…
2024-09-25	high	Boston Scientific Corporation — Class II recall: Flexima Regular Kit Nephrostomy Catheter System Kit, Material Numbers REF M00127…
2024-09-25	high	Boston Scientific Corporation — Class II recall: Flexima Regular Kit Biliary Catheter System Kit, Material Numbers REF M001271650…
2024-08-07	high	Boston Scientific Corporation — Class II recall: Capio SLIM Suture Capturing Device, Box of 5, Outer Package UPN: M0068318261, In…
2024-08-07	high	Boston Scientific Corporation — Class II recall: Capio SLIM Suture Capturing Device, 1-Pack, UPN: M0068318250. Capio SLIM Suture…
2024-07-24	high	Boston Scientific Corporation — Class II recall: Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M005…
2024-05-22	critical	Boston Scientific Corporation — Class I recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO LCB (5PK), REF H749085…
2024-05-22	critical	Boston Scientific Corporation — Class I recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO KIMNY (5PK), REF H7490…
2024-05-22	critical	Boston Scientific Corporation — Class I recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (5PK), REF H7490852…
2024-05-22	critical	Boston Scientific Corporation — Class I recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (5PK), REF H749085…
2024-05-22	critical	Boston Scientific Corporation — Class I recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMT (5PK), REF H749085…
2024-05-22	critical	Boston Scientific Corporation — Class I recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (SGL), REF H7490852…
2024-05-22	critical	Boston Scientific Corporation — Class I recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO TIG4 (5PK), REF H74908…
2024-05-22	critical	Boston Scientific Corporation — Class I recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (SGL), REF H749085…
2024-05-22	critical	Boston Scientific Corporation — Class I recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR6 (5PK), REF H749085…
2024-05-22	critical	Boston Scientific Corporation — Class I recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 MOD (5PK), REF H74…
2024-05-22	critical	Boston Scientific Corporation — Class I recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS2.5 (5PK), REF H749…
2024-05-22	critical	Boston Scientific Corporation — Class I recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3),…
2024-05-22	critical	Boston Scientific Corporation — Class I recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (SGL), REF H…
2024-05-22	critical	Boston Scientific Corporation — Class I recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 125CM (5PK), REF H…
2024-05-22	critical	Boston Scientific Corporation — Class I recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR1 (5PK), REF H749085…
2024-05-22	critical	Boston Scientific Corporation — Class I recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4.5 (5PK), REF H7490…
2024-05-22	critical	Boston Scientific Corporation — Class I recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR2 (5PK), REF H749085…
2024-05-22	critical	Boston Scientific Corporation — Class I recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL1 (5PK), REF H749085…
2024-05-22	critical	Boston Scientific Corporation — Class I recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3.5 (5PK), REF H7490…
2024-05-22	critical	Boston Scientific Corporation — Class I recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM 125CM (5PK), REF H7…
2024-05-22	critical	Boston Scientific Corporation — Class I recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (SGL), REF H749085…
2024-05-22	critical	Boston Scientific Corporation — Class I recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 125CM (5PK), REF H…
2024-05-22	critical	Boston Scientific Corporation — Class I recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMC (5PK), REF H749085…
2024-05-22	critical	Boston Scientific Corporation — Class I recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 125CM (5PK), REF H…
2024-05-22	critical	Boston Scientific Corporation — Class I recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR MOD (5PK), REF H749…
2024-05-22	critical	Boston Scientific Corporation — Class I recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL2 (5PK), REF H749085…
2024-05-22	critical	Boston Scientific Corporation — Class I recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3 (5PK)REF H74908526…
2024-05-22	critical	Boston Scientific Corporation — Class I recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR3.5 (5PK), REF H7490…
2024-05-22	critical	Boston Scientific Corporation — Class I recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3),…
2024-05-22	critical	Boston Scientific Corporation — Class I recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL6 (5PK), REF H749085…
2024-05-22	critical	Boston Scientific Corporation — Class I recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS4 (5PK), REF H74908…
2024-05-22	critical	Boston Scientific Corporation — Class I recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3.5 (5PK), REF H749…
2024-05-22	critical	Boston Scientific Corporation — Class I recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL3 (5PK), REF H749085…
2024-05-22	critical	Boston Scientific Corporation — Class I recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 125CM (5PK), REF H…
2024-05-22	critical	Boston Scientific Corporation — Class I recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3),…
2024-05-22	critical	Boston Scientific Corporation — Class I recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 155 (5PKX3),…
2024-05-22	critical	Boston Scientific Corporation — Class I recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (5PKX3), REF…
2024-05-22	critical	Boston Scientific Corporation — Class I recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 (5PK), REF H749085…
2024-05-22	critical	Boston Scientific Corporation — Class I recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM (5PK), REF H7490852…
2024-05-22	critical	Boston Scientific Corporation — Class I recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (SGL), R…
2024-05-22	critical	Boston Scientific Corporation — Class I recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO RCB (5PK), REF H749085…
2024-05-22	critical	Boston Scientific Corporation — Class I recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3 (5PK), REF H74908…
2024-05-22	critical	Boston Scientific Corporation — Class I recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 (5PK), REF H749085…
2024-05-22	critical	Boston Scientific Corporation — Class I recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CAS1 (5PK), REF H74908…
2024-05-22	critical	Boston Scientific Corporation — Class I recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO JIG3.5 (5PK), REF H749…
2024-05-22	critical	Boston Scientific Corporation — Class I recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 (5PK), REF H749085…
2024-05-22	critical	Boston Scientific Corporation — Class I recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO JIG4 (5PK), REF H74908…
2024-05-22	critical	Boston Scientific Corporation — Class I recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (5PK), REF H749085…
2024-04-17	high	Boston Scientific Corporation — Class II recall: EndoVive 20Fr Push Safety PEG Kit w/ENFit (Box 2)-Indicated for enteral nutritio…
2024-04-17	high	Boston Scientific Corporation — Class II recall: EndoVive 20Fr Push Standard PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrit…
2024-04-17	high	Boston Scientific Corporation — Class II recall: EndoVive 20Fr Push Safety PEG Kit (Box 2)-Indicated for enteral nutrition direct…
2024-04-17	high	Boston Scientific Corporation — Class II recall: EndoVive 20Fr Push Standard PEG Kit (Box 2)-Indicated for enteral nutrition dire…
2024-04-17	high	Boston Scientific Corporation — Class II recall: EndoVive 20 Fr Safety PEG Push w/ENFit Kit (Box 2)-Indicated for enteral nutriti…
2024-04-03	critical	Boston Scientific Corporation — Class I recall: Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013…
2024-04-03	critical	Boston Scientific Corporation — Class I recall: Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050
2024-04-03	high	Boston Scientific Corporation — Class II recall: Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitate…
2024-04-03	high	Boston Scientific Corporation — Class II recall: OptiCross Coronary Imaging Catheter, REF H749518080120
2024-02-28	high	Boston Scientific Corporation — Class II recall: EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or…
2024-01-17	high	Boston Scientific Corporation — Class II recall: Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) ins…
2023-11-29	high	Boston Scientific Corporation — Class II recall: EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN#…
2023-11-29	high	Boston Scientific Corporation — Class II recall: EXALT Model D Single-Use Duodenoscope, 2 pack: Outer box UPN# M00542421, Inner b…
2023-10-11	high	Boston Scientific Corporation — Class II recall: Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog number H965100460, c…
2023-10-11	high	Boston Scientific Corporation — Class II recall: Guider Softip Guide Catheter 7F 100CM MULTI PURPOSE, Catalog number M003101470,…
2023-10-11	high	Boston Scientific Corporation — Class II recall: Guider Softip Guide Catheter 6F 100CM MULTI PURPOSE, Catalog number M003101460,…
2023-10-11	high	Boston Scientific Corporation — Class II recall: Guider Softip Guide Catheter 8F 90CM MULTI PURPOSE, Catalog number H965100480, c…
2023-10-11	high	Boston Scientific Corporation — Class II recall: Guider Softip Guide Catheter 7F 90CM MULTI PURPOSE, Catalog number H965100470, c…
2023-10-11	high	Boston Scientific Corporation — Class II recall: Guider Softip Guide Catheter 5F PRE-SHAPED 40 100CM, Catalog number M003101620,…
2023-10-11	high	Boston Scientific Corporation — Class II recall: Guider Softip Guide Catheter 5F 90CM MULTI PURPOSE, Catalog number M003100630, c…
2023-10-11	high	Boston Scientific Corporation — Class II recall: Guider Softip Guide Catheter 8F 100CM MULTI PURPOSE, Catalog number M003101480,…
2023-10-11	high	Boston Scientific Corporation — Class II recall: Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, c…
2023-10-11	high	Boston Scientific Corporation — Class II recall: Guider Softip Guide Catheter 5F 100CM MULTI PURPOSE, Catalog number M003101630,…
2023-10-11	high	Boston Scientific Corporation — Class II recall: Guider Softip Guide Catheter 6F PRE-SHAPED 40 100CM, Catalog number M003101420,…
2023-10-11	high	Boston Scientific Corporation — Class II recall: Guider Softip Guide Catheter 8F PRE-SHAPED 40 90CM, Catalog number H965100440, c…
2023-10-11	high	Boston Scientific Corporation — Class II recall: Guider Softip Guide Catheter 5F PRE-SHAPED 40 90CM, Catalog number M003100620, c…
2023-10-11	high	Boston Scientific Corporation — Class II recall: Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, c…
2023-10-11	high	Boston Scientific Corporation — Class II recall: Guider Softip Guide Catheter 8F PRE-SHAPED 40 100CM, Catalog number M003101440,…
2023-10-11	high	Boston Scientific Corporation — Class II recall: Guider Softip Guide Catheter 7F PRE-SHAPED 40 100CM, Catalog number M003101430,…
2023-08-30	high	Boston Scientific Corporation — Class II recall: EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter D…
2023-08-30	high	Boston Scientific Corporation — Class II recall: EMBLEM MRI S-ICD Pulse Generator Model A219; Subcutaneous Implantable Cardiovert…
2023-08-02	high	Boston Scientific Corporation — Class II recall: Flexiva Pulse ID 242 TracTip single Use Fiber-intended to be used as a device th…
2023-08-02	high	Boston Scientific Corporation — Class II recall: Flexiva Pulse 242 ID Trac Single Use Fiber-intended to be used as a device that…
2023-08-02	high	Boston Scientific Corporation — Class II recall: Flexiva Pulse 242 TracTip Single-Use Laser Fibers - intended to be used as a dev…
2023-08-02	high	Boston Scientific Corporation — Class II recall: Flexiva Pulse 242 Single-Use Laser Fibers-intended to be used as a device that t…
2023-08-02	high	Boston Scientific Corporation — Class II recall: Flexiva Pulse 242 TracTip Single-Use Laser Fibers -intended to be used as a devi…
2023-08-02	high	Boston Scientific Corporation — Class II recall: Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser ene…
2023-08-02	high	Boston Scientific Corporation — Class II recall: Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser ene…
2023-05-24	high	Boston Scientific Corporation — Class II recall: WATCHDOG ACCESSORY KIT (20-PACK), UPN H74939343A021 (outer package), UPN H749393…
2023-05-24	high	Boston Scientific Corporation — Class II recall: WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A…
2023-04-26	high	Boston Scientific Corporation — Class II recall: Habib EndoHPB Bipolar Radiofrequency (RF) Catheter 8F (2.7mm). A radiofrequency…
2023-03-15	high	Boston Scientific Corporation — Class II recall: LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Softwa…

Coverage

FDA recalls Boston Scientific pacemaker after injuries, deaths. What patients should do. ↗— UCHealth Today
FDA issues most serious recall for certain pacemaker devices by Boston Scientific ↗— American Hospital Association
How Boston Scientific’s 2026 Guidance Cut and Pump Recall Has Changed Its Investment Story ↗— Simply Wall St

⬇ Download full CSV View Boston Scientific Corporation company page

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Full FDA history for Boston Scientific Corporation

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Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Verified from FDA.gov · Last updated: Jul 8, 2026

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). Boston Scientific Corporation: FDA Enforcement History. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/enforcement/boston-scientific-corporation

MLA

"Boston Scientific Corporation: FDA Enforcement History." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/enforcement/boston-scientific-corporation.

Chicago

Argus HQ Research. "Boston Scientific Corporation: FDA Enforcement History." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/enforcement/boston-scientific-corporation.

BibTeX

@misc{argushq_argushq_ai_enforcement_boston_scientific_corporation_2026,
  title = {Boston Scientific Corporation: FDA Enforcement History},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/enforcement/boston-scientific-corporation},
  note = {Accessed: July 23, 2026}
}

Source: FDA.gov (aggregated device recalls) ↗

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