Boston Scientific FARADRIVE Steerable Sheath recalled for air embolism risk from valve damage
Boston Scientific FARADRIVE Steerable Sheath recalled for air embolism risk
Boston Scientific identified that certain lots of the FARADRIVE Steerable Sheath (CLEAR) may have a hemostatic valve that can be damaged during device preparation if the dilator is not inserted correctly. Valve damage can allow air to enter, potentially causing an air embolism and patient harm.
- If you use this device, insert the dilator straight through the center of the valve and fully advance it into the sheath body during preparation.
- Check the lot number on your device against the affected lots listed in the recall notice.
- Contact Boston Scientific if you have questions about proper dilator insertion or your device lot number.
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2756-2026More Boston Scientific Corporation recalls
- FDA-Device2026-07-29Boston Scientific FARADRIVE steerable sheath recalled for air embolism risk from valve damage
- FDA-Device2026-07-29Boston Scientific FARASTAR PFA Generator recalled for catheter incompatibility
- FDA-Device2026-07-29Boston Scientific FARASTAR Ablation Generator recalled for incomplete instructions
- FDA-Device2026-07-29Boston Scientific FARASTAR PFA Generator recalled for incomplete instructions
- FDA-Device2026-07-29Boston Scientific FARASTAR PFA Generator recalled for incomplete labeling
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