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fda_recall · device_recall · high

Boston Scientific Corporation — Class II recall: FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vascul…

Event date
2026-07-29 00:00:00Z
Observed
2026-08-04 04:20:55Z
Source ID
Z-2756-2026
Payload hash
a1d33171d20d2985f992b342…

Summary

Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient… Status: Ongoing.

Entities

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Frequently asked questions

Has Boston Scientific Corporation had other FDA enforcement actions?
Yes. Argus HQ has recorded 292 total FDA actions tied to Boston Scientific Corporation: 0 warning letters, 292 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 2026-07-29; Argus observed and indexed it on 2026-08-04.
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 II recall: FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vascul…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-boston-scientific-corporation-z-2756-2026
MLA
"Boston Scientific Corporation — Class II recall: FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vascul…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-boston-scientific-corporation-z-2756-2026.
Chicago
Argus HQ Research. "Boston Scientific Corporation — Class II recall: FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vascul…." Digital Empire Holdings LLC. Accessed September 18, 2026. https://argushq.ai/events/fda-recall-boston-scientific-corporation-z-2756-2026.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_boston_scientific_corporation_z_2756_2026_2026,
  title = {Boston Scientific Corporation — Class II recall: FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vascul…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-boston-scientific-corporation-z-2756-2026},
  note = {Accessed: September 18, 2026}
}

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

Boston Scientific Corporation — Class II recall: FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vascul… · Argus HQ