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 2024-04-03; 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: Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050

Name: FDA Recall Record — Boston Scientific Corporation
Creator: Argus HQ
Published: 2024-04-03
License: https://argushq.ai/methodology

Event date: 2024-04-03 00:00:00Z
Observed: 2026-07-16 23:20:09Z
Source ID: Z-1302-2024
Payload hash: 8a4321ad3f7623c668ea8c47…

Summary

Boston Scientific has identified a tooling error in manufacturing which may have caused delamination of the inner lumen of the sheath shaft in a subset of POLARSHEATH devices. This could result in the embolization of a fragment during use (such as flushing of the sheath or introduction of the dilato… 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 2024-04-03; 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 (2024). Boston Scientific Corporation — Class I recall: Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-boston-scientific-corporation-z-1302-2024

MLA

"Boston Scientific Corporation — Class I recall: Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050." Argus HQ Research, Digital Empire Holdings LLC, 2024, argushq.ai/events/fda-recall-boston-scientific-corporation-z-1302-2024.

Chicago

Argus HQ Research. "Boston Scientific Corporation — Class I recall: Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-boston-scientific-corporation-z-1302-2024.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_boston_scientific_corporation_z_1302_2024_2024,
  title = {Boston Scientific Corporation — Class I recall: Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050},
  author = {{Argus HQ Research}},
  year = {2024},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-boston-scientific-corporation-z-1302-2024},
  note = {Accessed: July 23, 2026}
}

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