medical Class II Updated 2025-02-05

Boston Scientific Corporation recalls AXIOS Stent and Electrocautery- Enhanced Delivery System 10m

Recalled Product

AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553640

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: 08714729904588 Lot Numbers: 32891042, 32900457, 32908438, 33215358, 33215359, 33216060, 33216062, 33219660, 33219662, 33219663, 33315967, 33315970, 33324398, 33500190, 33520871, 33520872, 33537659, 33538481, 33538484, 33559005, 33813654, 33813655, 33871244, 33948086, 33996038, 33996039, 34004999, 34116469, 34116470, 34251352, 34251353, 34261614, 34261615, 34261616, 34263376, 34263377, 34277689, 34277690, 34297653, 34297657, 34512952, 34526862
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