FARADRIVE Steerable Sheath Clear IDE Recall for Air Embolism Risk
Boston Scientific recalls 400 units of a cardiac catheter sheath due to potential air embolism risk from valve damage during preparation.
- Product
- 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
- Category
- Medical Device
- Distribution
- Distributed nationwide