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FDA-Device2026-02-11Class IPROCESSING DEFECT

Boston Scientific AXIOS Stent 20mm x 10mm recalled for deployment and expansion issues

Boston Scientific
OTHERNationwide distribution

Stop using Boston Scientific AXIOS Stent

Boston Scientific has recalled specific lots of the AXIOS Stent and Electrocautery-Enhanced Delivery System (20mm x 10mm) due to reports of stent deployment and expansion problems. In some cases, the stent may not deploy or expand properly, which could require additional procedures to remove the stent and repair the puncture site.

  • If you have received or implanted one of the affected lot numbers listed in this recall, contact your healthcare provider immediately.
  • Do not use any AXIOS Stent from the affected lots.
  • Healthcare facilities should quarantine and return affected devices to 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.

Sold states
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.
Affected count
557 units
Manufactured in
100 Boston Scientific Way, N/A, Marlborough, MA, United States
Products
AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material Number (UPN): M00553660;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1158-2026

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