Boston Scientific Corporation recalls FARADRIVE Steerable Sheath Clear IDE
- Recalling company
- 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 – may cause temporary or medically reversible health consequences
- Recall date
- Jun 11, 2026
- Reported
- Jul 29, 2026
- Distribution
- Global Distribution. US Nationwide.
- Status
- Ongoing
- Quantity
- 400 units
- Lot / codes
- UDI-DI: 00810087181062; Lots: CL12910, CL12978, CL15153
- Company location
- Saint Paul, MN
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2754-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2754-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.