HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UPN): M00553520;

Reason: 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.

Code information: Material Number (UPN): M00553520; UDI-DI: 8714729904540; Lot Numbers: 36067957, 36067958, 36067959, 36067960, 36067961, 36099410, 36102139, 36111317, 36111318, 36111319, 36132439, 36132800, 36136724, 36136725, 36144054, 36154527, 36154528, 36154529, 36156019, 36164532, 36164990, 36176206, 36176207, 36177448, 36191239, 36199389, 36199390, 36217761, 36241713, 36251361, 36252913, 36271441, 36271442, 36281910, 36281911, 36292639, 36292680, 36292681, 36293836, 36300838, 36317858, 36317859, 36318240, 36323786, 36323787, 36331036, 36331037, 36331038, 36331039, 36397921, 36397922, 36397923, 36421238, 36424644, 36424645, 36427248, 36446498, 36447200, 36447201, 36449569, 36449570, 36449571, 36458829, 36459567, 36459568, 36459569, 36459570, 36461959, 36462320, 36468392, 36468393, 36468394, 36502795, 36506161, 36506163, 36509326, 36520053, 36523274, 36528114, 36536932, 36536933, 36548030, 36548031, 36548850, 36548851, 36552680, 36559035, 36559036, 36567446, 36567447, 36567448, 36574150, 36581585, 36581586, 36582790, 36582791, 36585188, 36585189, 36591087, 36592499, 36592660, 36596040, 36596041, 36609818, 36609819, 36610400, 36610401, 36621583, 36621584, 36634546, 36634547, 36664793, 36673195, 36673557, 36673558, 36675688, 36675689, 36675690, 36675692, 36677844, 36677845, 36677846, 36680231, 36680232, 36683260, 36683261, 36683262, 36693971, 36693972, 36717713, 36717714, 36717715, 36717819, 36721863, 36731805, 36731806, 36738965, 36738966, 36743835, 36750922, 36750924, 36753179, 36753400, 36781577, 36781578, 36781579, 36784378, 36784379, 36788332, 36788333, 36788334, 36792650, 36799316, 36832750, 36832837, 36832838, 36833682, 36834573, 36843542, 36844231, 36846161, 36846163, 36864951, 36864952, 36865501, 36865502, 36865504, 36865553, 36868065, 36872344, 36872346, 36878419, 36884609, 36884612, 36884613, 36895367, 36895368, 36896664, 36907033, 36907249, 36907378, 36907400, 36914565, 36915206, 36915207, 36916329, 36916330, 36917403, 36917404, 36917993, 37000847, 37003365, 37423232, 37423233, 37427258, 37427259, 37427360, 37427361, 37427362, 37437936, 37438283, 37438286, 37438287, 37439978, 37440320, 37451304, 37456594, 37457216, 37457217, 37457269, 37459571, 37463623, 37463624, 37463625, 37463628, 37469756, 37469757, 37469758, 37470669, 37472148, 37475121, 37475122, 37481983, 37486079, 37518915, 37518916, 37518917, 37519094, 37532420, 37532421, 37533309, 37543372, 37558499, 37558542, 37567252, 37567253, 37567400, 37568848, 37568849, 37571930, 37685005, 37686597, 37689957, 37689958, 37698144, 37704842, 37761033, 37761034, 37775246, 37776579, 37776720, 37776721, 37780826, 37785688, 37785689, 37811064, 37817121, 37823587, 37823588, 37826529, 37826530, 37827570, 37834839, 37836866, 37836867, 37842827;

Distribution pattern: Worldwide distribution. US Nationwide including Puerto Rico; Algeria, Argentina, Austria, Belgium, Brazil, Canada, CHILE, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, JAPAN, Jordan, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, PERU, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, UAE, and United Kingdom.