Boston Scientific Corporation recalls HOT AXIOS Stent and Electrocautery- Enhanced Delivery System
Recalled Product
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553570
Hazard / Issue
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Issued by
FDA
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