Z-1163-2026 Class I Ongoing

*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material Number (UPN): M00553560;

Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.

Material Number (UPN): M00553560; UDI-DI: 8714729951100; Lot Numbers: 35793920, 35952745, 35961004, 35995006, 35995007, 35995165, 36001950, 36001951, 36001952, 36001953, 36002902, 36002903, 36002904, 36003946, 36003947, 36003948, 36012845, 36012846, 36012847, 36012848, 36015761, 36021049, 36021050, 36021051, 36021052, 36027054, 36027055, 36027056, 36027057, 36027058, 36027059, 36027060, 36027061, 36038410, 36038411, 36040000, 36040001, 36040002, 36040003, 36040004, 36048795, 36048796, 36048797, 36048798, 36049282, 36049283, 36049284, 36050387, 36050388, 36050389, 36059222, 36059223, 36059224, 36059225, 36062077, 36062078, 36062079, 36064449, 36065116, 36065117, 36067962, 36067963, 36067964, 36069958, 36069959, 36070600, 36070608, 36070609, 36070610, 36070611, 36072736, 36072737, 36092333, 36092334, 36092335, 36099411, 36099412, 36099413, 36101743, 36101744, 36101745, 36101746, 36101747, 36102812, 36102813, 36102814, 36135590, 36135591, 36144122, 36144123, 36147096, 36147097, 36154534, 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