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 2026-02-11; 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: *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Mat…

Name: FDA Recall Record — Boston Scientific Corporation
Creator: Argus HQ
Published: 2026-02-11
License: https://argushq.ai/methodology

Event date: 2026-02-11 00:00:00Z
Observed: 2026-07-16 23:20:09Z
Source ID: Z-1163-2026
Payload hash: e9b1e3498088854a39b62d58…

Summary

Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first fl… 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 2026-02-11; 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 (2026). Boston Scientific Corporation — Class I recall: *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System   20mm x 10mm;  Mat…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-boston-scientific-corporation-z-1163-2026

MLA

"Boston Scientific Corporation — Class I recall: *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System   20mm x 10mm;  Mat…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-boston-scientific-corporation-z-1163-2026.

Chicago

Argus HQ Research. "Boston Scientific Corporation — Class I recall: *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System   20mm x 10mm;  Mat…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-boston-scientific-corporation-z-1163-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_boston_scientific_corporation_z_1163_2026_2026,
  title = {Boston Scientific Corporation — Class I recall: *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System   20mm x 10mm;  Mat…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-boston-scientific-corporation-z-1163-2026},
  note = {Accessed: July 23, 2026}
}

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