medical Class II Updated 2025-02-05

Boston Scientific Corporation recalls AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740

Recalled Product

AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740


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: 08714729904625 Lot Numbers: 34477280
View official government recall

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