medical Class II Updated 2025-02-05

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

Distribution: Nationwide (United States)
Lot/Code Info: GTIN: 08714729976684 Lot Numbers: 32878539, 33336847, 33338446, 33775901, 33795273, 33900261, 33900262, 34076575, 34083270, 34172108, 34172109
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