Boston Scientific Corporation: Catheter, Steerable
Recall Summary Boston Scientific is recalling certain FARADRIVE STEERABLE SHEATH CLEAR catheters (Model 21M402) used to access blood vessels and heart chambers. The valve in some devices can be damaged during preparation if the dilator is inserted at an incorrect angle, potentially allowing air to enter the device and cause serious harm to patients. This recall affects devices distributed nationwide across the United States.
- Recalling firm
- Boston Scientific Corporation
- Product
- FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402, IFU Reference Number LBL1062
- 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/c8109cad-8b6f-4b79-8cda-ccd4f6a932bc