Z-1162-2026Class I

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

Name: Z-1162-2026 *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Material Number (UPN): M00553530
Creator: Boston Scientific Corporation
Published: 2025-12-19
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2025-12-19 / Open, Classified / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Material Number (UPN): M00553530 on 2025-12-19. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1162-2026
Classification: Class I
Status: Open, Classified
Initiated: 2025-12-19
Posted: 2026-02-05
Recalling firm: Boston Scientific Corporation
Product: *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Material Number (UPN): M00553530;
Product code: KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On December 19, 2025, Urgent Medical Device Removal - Immediate Action Required letters were sent to customers. Actions to be taken: - Immediately stop further distribution or use of any remaining affected devices. Remove them from your facility s inventory and segregate them in a secure location until they can be returned to Boston Scientific. " Immediately post this information in a visible location near the affected products to ensure this information is readily accessible to all handlers and users of the device. " Share this notice with any health care professional within your organization and with any organization where the affected products may have been transferred. " If you are a distributor, this notification must be forwarded to your customers to ensure notification of this product removal is carried out to the end-user level. " If you are a facility that has sent products to another hospital or a facility within your network, ensure this notification is forwarded to them. " Boston Scientific reminds healthcare professionals that AXIOS Stents should only be used as indicated in Instructions For Use.
Quantity in commerce: 150 units
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.
Product codes and lots: 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;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1162-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1158-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-05
Z-1159-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-05
Z-1160-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-05
Z-1161-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-05
Z-1162-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-05
Z-1163-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-05

Product code KNS

K233318Class IIAXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (8mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (10mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (20mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx15mm)Boston Scientific Corporation / cleared 2023-10-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)