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FDA-Device2026-02-11Class IPROCESSING DEFECT

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

Boston Scientific
OTHERNationwide distribution

Check your AXIOS Stent lot number immediately

Boston Scientific's AXIOS Stent (a medical device used in certain procedures) may fail to deploy or expand properly during use. If the stent does not expand as intended, patients may need additional procedures—either endoscopic or surgical—to remove the stent and repair the site.

  • If you received this stent, contact your healthcare provider with your lot number immediately
  • Healthcare providers should check the affected lot numbers listed in the recall notice
  • Do not use any AXIOS Stent matching the recalled lot numbers
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
588 units
Manufactured in
100 Boston Scientific Way, N/A, Marlborough, MA, United States
Products
*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material Number (UPN): M00553560;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1163-2026

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