Boston Scientific Corporation: Catheter, Steerable

Recall Summary Boston Scientific is recalling certain FARADRIVE Steerable Sheaths (Material Number 21C602) used to access blood vessels and heart chambers during cardiac procedures. The sheaths can develop valve damage during preparation if the dilator is inserted at an incorrect angle, which may allow air to enter the device and potentially harm patients. This risk can be reduced by inserting the dilator straight through the valve's center and fully advancing it into the sheath.

Recalling firm: Boston Scientific Corporation
Product: FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21C602, IFU Reference Number 51636751-01
Reason: 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 harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.
Classification: Class II
Category: medical device recall
Country: United States
Agency: FDA-DEVICES
Recall date: 2026-06-11
Status: Open, Classified
Areas affected: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution: Global Distribution. US Nationwide.

Recall details on Nibble Recalls: https://trynibble.app/recalls/c7bc8ad2-7c02-4a4e-97ae-bf085ae76838