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Boston Scientific Corporation recalls AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number (UPN): M00553680;
Recalled February 11, 2026 · FDA recall Z-1159-2026 · Boston Scientific
Hazard
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. · FDA Class I
Units
39 units
Sold at
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.
Description
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.
Product
AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number (UPN): M00553680;
Manufacturer(s)
Boston Scientific Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →