FARADRIVE Steerable Sheath Clear IDE
Boston Scientific is recalling the FARADRIVE Steerable Sheath Clear IDE due to potential valve damage that may cause air embolism.
Healthcare providers should ensure the dilator is inserted straight through the center of the valve and fully advanced into the sheath body during device preparation to mitigate the risk of air ingress.
Why it was recalled
Boston Scientific is recalling the FARADRIVE Steerable Sheath Clear IDE due to potential hemostatic valve damage caused by improper dilator insertion. This damage may lead to air ingress and the risk of air embolism during use.
Is mine affected?
This recall covers the products below. If you have any of them, yours is affected.
| Product |
|---|
| FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004PFCE21M402, IFU Reference Number 51659727-01 |
| FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21C602, IFU Reference Number 51636751-01 |
| FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004PF21M402, IFU Reference Number 51654495-01 |
| FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402, IFU Reference Number LBL1062 |
Official source
Other recent recalls from Boston Scientific Corporation
Editorial summary by Recall Canary · last updated 2026-07-21 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification