Class I — UrgentReported 2026-02-11

*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Material Number (UPN): M00553530;

Recalled by Boston Scientific Corporation

Reason for Recall

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.

Recall Number

Z-1162-2026

Classification

Class I

Status

Ongoing

Category

device

Initiated

2025-12-19

Reported

2026-02-11

Distribution

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.

Code Info

Material Number (UPN): M00553530; UDI-DI: 8714729904557; Lot Numbers: 35985705, 35986358, 36147098, 36147222, 36165642, 36176423, 36190575, 36191222, 36194448, 36218745, 36227778, 36227779, 36241500, 36271259, 36280398, 36293880, 36300839, 36301620, 36343103, 36343104, 36364646, 36425887, 36469811, 36471228, 36491879, 36492660, 36506029, 36510220, 36510221, 36513401, 36513402, 36513403, 36517139, 36517220, 36525208, 36525209, 36525210, 36534514, 36534518, 36536259, 36536480, 36536481, 36551000, 36551001, 36642564, 36642565, 36642756, 36645775, 36663654, 36677842, 36677843, 36682759, 36684887, 36684888, 36730665, 36730666, 36747824, 36747825, 36753898, 36753899, 36757493, 36757494, 36761827, 36766370, 36766371, 36783265, 36792467, 36792468, 36792469, 36792470, 36792471, 36799315, 36815090, 36815092, 36832774, 36833683, 36836357, 36844783, 36845422, 36846169, 36846176, 36851617, 36851792, 36853596, 36865505, 36873631, 36873632, 36873906, 36874863, 36904228, 36904229, 36904230, 36907002, 36907003, 36907004, 36907028, 37102533, 37102534, 37102535, 37102536, 37102537, 37459567, 37459568, 37459569, 37459570, 37463133, 37470670, 37498192, 37511243, 37519095, 37519096, 37844029, 37519097, 37520927, 37530320, 37530321, 37530333, 37533308, 37541933, 37571927, 37571928, 37579364, 37579366, 37579367, 37580630, 37585525, 37585526, 37589261, 37589262, 37594668, 37649481, 37649482, 37649483, 37650631, 37694052, 37699011, 37699012, 37708202, 37779125, 37779126, 37780822, 37780823, 37780824, 37823589, 37823590, 37827568, 37827569, 37833165, 37833176, 37834499;

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.