medical Class II Updated 2025-02-05

Boston Scientific Corporation recalls AXIOS Stent and Electrocautery- Enhanced Delivery System 8mm

Recalled Product

AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553690

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: 00191506008093 Lot Numbers: 33419782, 33477824, 34116467, 33419783, 33511487
View official government recall

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