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 FARADRIVE Steerable Sheath devices may develop damage to the hemostatic valve if the dilator is not inserted correctly during preparation. Valve damage can allow air to enter the device, which may lead to air embolism—a serious condition where air bubbles reach the bloodstream and heart.
- Review the instructions for use (IFU Reference 51659727-01) before using this device.
- When preparing the device, insert the dilator straight through the center of the valve and fully advance it into the sheath body.
- If your facility has affected lot numbers, contact Boston Scientific for further guidance.
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-2757-2026More 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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