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

Reason: 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.

Code information: 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

Distribution pattern: Nationwide including Puerto Rico Foreign: To be provided