FDAFDA recall Z-2754-2026 · Jul 29, 2026
Boston Scientific Corporation: FARADRIVE Steerable Sheath Clear IDE recall
Recall found
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 for recall
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- UDI-DI: 00810087181062; Lots: CL12910, CL12978, CL15153
- Quantity
- 400 units
- Distribution
- Global Distribution. US Nationwide.
- Recalling firm
- Boston Scientific Corporation, Saint Paul, MN
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-06-11
Source: openFDA enforcement record Z-2754-2026 · search recall number Z-2754-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.