HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553560

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: 08714729951100 Lot Numbers: 32865866, 32874910, 32875944, 32876867, 32876869, 32876870, 33195387, 33195388, 33195389, 33195390, 33209841, 33209843, 33215357, 33283337, 33284518, 33284519, 33288532, 33288534, 33301346, 33301347, 33301348, 33301351, 33301352, 33466658, 33467021, 33470461, 33470464, 33470465, 33486865, 33487939, 33519203, 33528652, 33581298, 33581681, 33601247, 33657824, 33686163, 33686166, 33765267, 33804643, 33806748, 33909812, 33909813, 33920980, 33948082, 33977789, 33981155, 33981156, 34006718, 34015882, 34020432, 34020433, 34020434, 34027240, 34047363, 34065574, 34074522, 34076577, 34083205, 34085563, 34101925, 34102569, 34102570, 34102571, 34103179, 34103340, 34111453, 34111454, 34111456, 34111845, 34116472, 34116473, 34126522, 34180835, 34190940, 34190949, 34201914, 34205933, 34205934, 34213826, 34214585, 34214586, 34223572, 34223574, 34325972, 34325974, 34334692, 34335366, 34371087, 34371088, 34371090, 34523681, 34545213, 34649321, 34815303

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