Boston Scientific Corporation: Catheter, Steerable
Recall Summary Boston Scientific is recalling certain FARADRIVE STEERABLE SHEATH CLEAR OUS catheters used to access the heart's blood vessels and chambers because the hemostatic valve can be damaged during device preparation, potentially allowing air to enter the bloodstream. The issue occurs when the dilator is not inserted straight through the center of the valve during setup. This recall affects catheters distributed nationwide and globally.
- Recalling firm
- Boston Scientific Corporation
- Product
- FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004PFCE21M402, IFU Reference Number 51659727-01
- 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.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/2721d258-f407-4956-8a02-1acb771acb4d