Boston Scientific FARADRIVE steerable sheath recalled for air embolism risk from valve damage
Boston Scientific FARADRIVE sheath recalled for air embolism risk
Boston Scientific has identified that certain lots of the FARADRIVE steerable sheath may develop damage to the hemostatic valve during preparation if the dilator is not inserted correctly. This valve damage can allow air to enter the device, which may lead to air embolism (air in the bloodstream) 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.
- Review the updated Instructions for Use (IFU Reference LBL1062) for proper insertion technique.
- Contact Boston Scientific if you have questions about your device lot number or proper use.
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-2755-2026More Boston Scientific Corporation recalls
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