Has Boston Scientific Corporation had other FDA enforcement actions?

Yes. Argus HQ has recorded 272 total FDA actions tied to Boston Scientific Corporation: 0 warning letters, 272 recalls, 0 approval records, and 0 Form 483 inspection citations.

What kind of FDA record is this?

This is an Argus HQ record of a FDA Recall, tagged critical severity by Argus HQ. FDA published the underlying record on 2025-08-27; Argus observed and indexed it on 2026-07-16.

Where can I verify this record directly with FDA?

The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

.hq

fda_recall · device_recall · critical

Boston Scientific Corporation — Class I recall: ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardioverter…

Name: FDA Recall Record — Boston Scientific Corporation
Creator: Argus HQ
Published: 2025-08-27
License: https://argushq.ai/methodology

Event date: 2025-08-27 00:00:00Z
Observed: 2026-07-16 23:20:09Z
Source ID: Z-2325-2025
Payload hash: dfe89957cb44397e6b47d0e1…

Summary

Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation. Status: Ongoing.

Entities

Boston Scientific Corporation

View source record ↗

Frequently asked questions

Has Boston Scientific Corporation had other FDA enforcement actions?: Yes. Argus HQ has recorded 272 total FDA actions tied to Boston Scientific Corporation: 0 warning letters, 272 recalls, 0 approval records, and 0 Form 483 inspection citations.
What kind of FDA record is this?: This is an Argus HQ record of a FDA Recall, tagged critical severity by Argus HQ. FDA published the underlying record on 2025-08-27; Argus observed and indexed it on 2026-07-16.
Where can I verify this record directly with FDA?: The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

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 (2025). Boston Scientific Corporation — Class I recall: ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardioverter…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-boston-scientific-corporation-z-2325-2025

MLA

"Boston Scientific Corporation — Class I recall: ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardioverter…." Argus HQ Research, Digital Empire Holdings LLC, 2025, argushq.ai/events/fda-recall-boston-scientific-corporation-z-2325-2025.

Chicago

Argus HQ Research. "Boston Scientific Corporation — Class I recall: ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardioverter…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-boston-scientific-corporation-z-2325-2025.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_boston_scientific_corporation_z_2325_2025_2025,
  title = {Boston Scientific Corporation — Class I recall: ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardioverter…},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-boston-scientific-corporation-z-2325-2025},
  note = {Accessed: July 23, 2026}
}

Informational only. Not legal, financial, or medical advice.