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

6 total: 0 warning letters, 6 recalls, 0 approval records, and 0 Form 483 inspection citations.

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

July 1, 2026. Argus HQ ingests new FDA enforcement records daily.

Has Boston Scientific Corporation had product recalls?

Yes, 6 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.

Boston Scientific Corporation's Complete FDA Record

FDA action counts

Total FDA actions	6
Warning letters	0
Recalls	6
Approval records	0
Form 483 inspection citations	0
Most recent action	July 1, 2026

The short version: Argus HQ has recorded 6 FDA events for Boston Scientific Corporation: 0 warning letters, 6 recalls, 0 approvals, and 0 inspection 483 observations. These events span from 2026-05-06 to 2026-07-01. The most severe rating Argus HQ has assigned across this history is "critical". 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.

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?: 6 total: 0 warning letters, 6 recalls, 0 approval records, and 0 Form 483 inspection citations.
What is the most recent FDA action on file for Boston Scientific Corporation?: July 1, 2026. Argus HQ ingests new FDA enforcement records daily.
Has Boston Scientific Corporation had product recalls?: Yes, 6 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.

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

Cite this record

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

APA

Argus HQ Research (2026). Boston Scientific Corporation's Complete FDA Record. Digital Empire LLC. Retrieved from https://argushq.ai/company/boston-scientific-corporation

MLA

"Boston Scientific Corporation's Complete FDA Record." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/company/boston-scientific-corporation.

Chicago

Argus HQ Research. "Boston Scientific Corporation's Complete FDA Record." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/company/boston-scientific-corporation.

BibTeX

@misc{argushq_argushq_ai_company_boston_scientific_corporation_2026,
  title = {Boston Scientific Corporation's Complete FDA Record},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/company/boston-scientific-corporation},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov (aggregated across Warning Letters, Recalls, Approvals, Form 483s) ↗