Boston Scientific Steerable Sheath Recall Over Hemostatic Valve Damage
Boston Scientific is recalling its Faradrive Steerable Sheath devices due to potential hemostatic valve damage during preparation, which may cause air ingress and patient harm.
- 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
- Category
- Medical Device
- Distribution
- Distributed nationwide