Z-2754-2026 Class II Ongoing
FDA device recall Z-2754-2026 was initiated by Boston Scientific Corporation on June 11, 2026 and is designated Class II. 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 … The recall status is ongoing. Affected quantity: 400 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 29, 2026
- Initiation Date
- June 11, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 400 units
Product Description
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.
Distribution Pattern
Global Distribution. US Nationwide.
Code Information
UDI-DI: 00810087181062; Lots: CL12910, CL12978, CL15153