Boston Scientific FARADRIVE Steerable Sheath recalled for air embolism risk from valve damage
Boston Scientific FARADRIVE Sheath recalled for air embolism risk
Boston Scientific identified that improper dilator insertion during device setup can damage the hemostatic valve in the FARADRIVE Steerable Sheath. Valve damage may allow air to enter the device, potentially causing air embolism and patient harm. The risk occurs in a subset of affected units when the dilator is not inserted straight through the center of the valve.
- If you use or prepare this device, insert the dilator straight through the center of the hemostatic valve and fully advance it into the sheath body.
- Contact Boston Scientific if you have questions about proper insertion technique or if you have already experienced air ingress complaints.
- Report any adverse events or complications to Boston Scientific and the FDA.
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-2754-2026More 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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