Has Boston Scientific Corporation had other FDA enforcement actions?

Yes. Argus HQ has recorded 294 total FDA actions tied to Boston Scientific Corporation: 0 warning letters, 294 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 2026-09-30; Argus observed and indexed it on 2026-10-06.

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: Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5; M0…

Name: FDA Recall Record — Boston Scientific Corporation
Creator: Argus HQ
Published: 2026-09-30
License: https://argushq.ai/methodology

Event date: 2026-09-30 00:00:00Z
Observed: 2026-10-06 04:20:27Z
Source ID: Z-3214-2026
Payload hash: a8e53a9fc1e0406bf2708cd1…

Summary

Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact may include prolonged procedure or life-threatening embolism. 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 294 total FDA actions tied to Boston Scientific Corporation: 0 warning letters, 294 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 2026-09-30; Argus observed and indexed it on 2026-10-06.
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 (2026). Boston Scientific Corporation — Class I recall: Imager II Angiographic Catheters    M001314001  IMAGER II/5/ST/65/038 BX5;    M0…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-boston-scientific-corporation-z-3214-2026

MLA

"Boston Scientific Corporation — Class I recall: Imager II Angiographic Catheters    M001314001  IMAGER II/5/ST/65/038 BX5;    M0…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-boston-scientific-corporation-z-3214-2026.

Chicago

Argus HQ Research. "Boston Scientific Corporation — Class I recall: Imager II Angiographic Catheters    M001314001  IMAGER II/5/ST/65/038 BX5;    M0…." Digital Empire Holdings LLC. Accessed October 6, 2026. https://argushq.ai/events/fda-recall-boston-scientific-corporation-z-3214-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_boston_scientific_corporation_z_3214_2026_2026,
  title = {Boston Scientific Corporation — Class I recall: Imager II Angiographic Catheters    M001314001  IMAGER II/5/ST/65/038 BX5;    M0…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-boston-scientific-corporation-z-3214-2026},
  note = {Accessed: October 6, 2026}
}

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