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 high severity by Argus HQ. FDA published the underlying record on 2024-02-28; 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 · high

Boston Scientific Corporation — Class II recall: EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or…

Name: FDA Recall Record — Boston Scientific Corporation
Creator: Argus HQ
Published: 2024-02-28
License: https://argushq.ai/methodology

Event date: 2024-02-28 00:00:00Z
Observed: 2026-07-16 23:20:09Z
Source ID: Z-1153-2024
Payload hash: 9a6e52793ca4ed7d21dc5cbe…

Summary

Affected batches of the kit contain Stoma Measuring Devices sized to measure for an 18/24F replacement button, but are labeled as being for a 28F. Use of defective product may lead to undersizing the button, which may cause embedding with erosion into the gastric wall, tissue necrosis, infection, se… 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 high severity by Argus HQ. FDA published the underlying record on 2024-02-28; 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 II recall: EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-boston-scientific-corporation-z-1153-2024

MLA

"Boston Scientific Corporation — Class II recall: EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or…." Argus HQ Research, Digital Empire Holdings LLC, 2024, argushq.ai/events/fda-recall-boston-scientific-corporation-z-1153-2024.

Chicago

Argus HQ Research. "Boston Scientific Corporation — Class II recall: EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-boston-scientific-corporation-z-1153-2024.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_boston_scientific_corporation_z_1153_2024_2024,
  title = {Boston Scientific Corporation — Class II recall: EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or…},
  author = {{Argus HQ Research}},
  year = {2024},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-boston-scientific-corporation-z-1153-2024},
  note = {Accessed: July 23, 2026}
}

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