Boston Scientific Corporation's Complete FDA Record

FDA action counts

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Boston Scientific Corporation has 6 separate FDA recalls on file, more than a single isolated recall event. A pattern across multiple FDA touchpoints does not by itself establish that any specific product currently poses a risk; it reflects only the frequency of FDA engagement with this company as recorded in Argus HQ's database. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ does not independently verify FDA's underlying findings; this page summarizes what FDA has published and links back to the original FDA source for each event.

Enforcement history

On 2026-05-06, Argus HQ recorded a FDA recall for Boston Scientific Corporation, rated "critical" severity in Argus HQ's classification: Boston Scientific Corporation — Class I recall: Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALIT… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-06, Argus HQ recorded a FDA recall for Boston Scientific Corporation, rated "critical" severity in Argus HQ's classification: Boston Scientific Corporation — Class I recall: Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardia… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-13, Argus HQ recorded a FDA recall for Boston Scientific Corporation, rated "high" severity in Argus HQ's classification: Boston Scientific Corporation — Class II recall: LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRA… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-13, Argus HQ recorded a FDA recall for Boston Scientific Corporation, rated "high" severity in Argus HQ's classification: Boston Scientific Corporation — Class II recall: LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUD… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-06-17, Argus HQ recorded a FDA recall for Boston Scientific Corporation, rated "high" severity in Argus HQ's classification: Boston Scientific Corporation — Class II recall: Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50;… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-07-01, Argus HQ recorded a FDA recall for Boston Scientific Corporation, rated "high" severity in Argus HQ's classification: Boston Scientific Corporation — Class II recall: Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. In total, Boston Scientific Corporation has 6 FDA events on file with Argus HQ across the sources Argus HQ currently tracks (FDA Warning Letters, recalls, drug/biologic approvals, and Form 483 inspection observations).

Frequently asked questions

How many FDA actions does Argus HQ track for Boston Scientific Corporation?

285 total: 0 warning letters, 285 recalls, 0 approval records, and 0 Form 483 inspection citations.

What is the most recent FDA action on file for Boston Scientific Corporation?

August 12, 2026. Argus HQ ingests new FDA enforcement records daily.

Has Boston Scientific Corporation had product recalls?

Yes, 285 recalls on file. See the full history below for each one.

Is this FDA enforcement data for Boston Scientific Corporation official?

Every record links directly to its primary FDA.gov source. Argus HQ aggregates and structures public FDA data; the verbatim FDA record is always the source of truth.

Related enforcement actions

• Boston Scientific Corporation — Class II recall: Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions an… →
• Boston Scientific Corporation — Class II recall: Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and U… →
• Boston Scientific Corporation — Class II recall: Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN:… →
• Boston Scientific Corporation — Class II recall: FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation… →
• Boston Scientific Corporation — Class II recall: FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M4… →
• Boston Scientific Corporation — Class II recall: FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculatu… →
• Boston Scientific Corporation — Class II recall: FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculatu… →
• Boston Scientific Corporation — Class II recall: FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vascul… →
• Boston Scientific Corporation — Class II recall: FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneou… →
• Boston Scientific Corporation — Class II recall: FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature a… →

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