Recall archive / FDA device enforcement

*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Material Number (UPN): M00553530; — FDA record Z-1162-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Dec 19, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Material Number (UPN): M00553530;
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.
Classification: Class I
Recalling firm: Boston Scientific Corporation
Quantity: 150 units
Agency-reported status: Ongoing
Source record identifier: Z-1162-2026

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What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	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;

Label field

Details supplied by the agency

Lot, code or applicability

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;

Match all identifying details in the current notice. A brand name alone is not enough.

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.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Feb 11, 2026
Recall initiation date: Dec 19, 2025
Center classification date: Feb 5, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

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