AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553650

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: 08714729904595 Lot Numbers: 32891503, 32946481, 32966087, 32976911, 32986912, 32986913, 32986914, 32996152, 33004776, 33004777, 33004779, 33008425, 33527176, 33547873, 33559652, 33562171, 33568700, 33568705, 33568709, 33580106, 33686169, 33686170, 33686171, 33686172, 33996104, 33996109, 34006713, 34052770, 34052771, 34052772, 34052773, 34065575, 34065576, 34065577, 34065578, 34136366, 33008426, 33008427, 33013790, 33013791, 33038652, 33158792, 33161956, 33219664, 33219665, 33223921, 33223922, 33223925, 33233417, 33233418, 33233419, 33233460, 33233461, 33235723, 33487216, 33487218, 33489572, 33527175, 33686173, 33686174, 33765268, 33765269, 33765271, 33765272, 33765273, 33765274, 33766684, 33775698, 33813656, 33813657, 33813658, 33813659, 33825083, 33825084, 33825087, 33825091, 33873459, 33873923, 33881493, 33996102, 34136369, 34136370, 34142870, 34142871, 34144414, 34144416, 34251354, 34261613, 34261617, 34261618, 34261619, 34263374, 34271464, 34271465, 34276937, 34276938, 34277681, 34286615, 34286616, 34286617, 34286618, 34308441

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