AXIOS Stent Delivery System: Detaching Outer Sheath May Prevent Stent Expansion
Boston Scientific is recalling 1,144 AXIOS Stent Delivery System units because the outer sheath's distal black tip can detach. If this occurs, the tip may remain around the stent saddle and prevent proper stent expansion, requiring device exchange.
- Product
- AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553650
- Category
- Medical Device
- Distribution
- Distributed nationwide