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 2025-09-17; 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: Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN): 1. H749…

Name: FDA Recall Record — Boston Scientific Corporation
Creator: Argus HQ
Published: 2025-09-17
License: https://argushq.ai/methodology

Event date: 2025-09-17 00:00:00Z
Observed: 2026-07-16 23:20:09Z
Source ID: Z-2533-2025
Payload hash: 592efcb5ed30568b9d25c548…

Summary

The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dil… 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 2025-09-17; 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 II recall: Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN):    1.	H749…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-boston-scientific-corporation-z-2533-2025

MLA

"Boston Scientific Corporation — Class II recall: Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN):    1.	H749…." Argus HQ Research, Digital Empire Holdings LLC, 2025, argushq.ai/events/fda-recall-boston-scientific-corporation-z-2533-2025.

Chicago

Argus HQ Research. "Boston Scientific Corporation — Class II recall: Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN):    1.	H749…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-boston-scientific-corporation-z-2533-2025.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_boston_scientific_corporation_z_2533_2025_2025,
  title = {Boston Scientific Corporation — Class II recall: Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN):    1.	H749…},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-boston-scientific-corporation-z-2533-2025},
  note = {Accessed: July 23, 2026}
}

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