FARADRIVE Steerable Sheath Clear IDE recall
FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21C602, IFU…
Why was FARADRIVE Steerable Sheath Clear IDE recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 00810087181062; Lots: CL12910, CL12978, CL15153
- Product
- FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21C602, IFU…
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 400 units
- Distribution
- Global Distribution. US Nationwide.
- Recall date
- July 29, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)