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fda_recall · device_recall · critical

Boston Scientific Corporation — Class I recall: WATCHMAN TruSeal Access System ANT, US, Material Number (UPN) M635TU70040; inten…

Event date
2025-09-10 00:00:00Z
Observed
2026-07-16 23:20:09Z
Source ID
Z-2433-2025
Payload hash
23832afb17325c53dfe2327d…

Summary

Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious o… Status: Ongoing.

Entities

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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 2025-09-10; 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 I recall: WATCHMAN TruSeal Access System ANT, US, Material Number (UPN) M635TU70040; inten…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-boston-scientific-corporation-z-2433-2025
MLA
"Boston Scientific Corporation — Class I recall: WATCHMAN TruSeal Access System ANT, US, Material Number (UPN) M635TU70040; inten…." Argus HQ Research, Digital Empire Holdings LLC, 2025, argushq.ai/events/fda-recall-boston-scientific-corporation-z-2433-2025.
Chicago
Argus HQ Research. "Boston Scientific Corporation — Class I recall: WATCHMAN TruSeal Access System ANT, US, Material Number (UPN) M635TU70040; inten…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-boston-scientific-corporation-z-2433-2025.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_boston_scientific_corporation_z_2433_2025_2025,
  title = {Boston Scientific Corporation — Class I recall: WATCHMAN TruSeal Access System ANT, US, Material Number (UPN) M635TU70040; inten…},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-boston-scientific-corporation-z-2433-2025},
  note = {Accessed: July 23, 2026}
}

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

Boston Scientific Corporation — Class I recall: WATCHMAN TruSeal Access System ANT, US, Material Number (UPN) M635TU70040; inten… · Argus HQ