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FDA-Device2026-02-11Class IPROCESSING DEFECT

Boston Scientific AXIOS Stent recalled for deployment and expansion issues

Boston Scientific
OTHERNationwide distribution

Contact your doctor about AXIOS Stent

Boston Scientific is recalling certain AXIOS Stents (8mm x 8mm) due to reports of deployment and expansion problems during use. If a stent fails to deploy properly, patients may need additional procedures to remove it and repair the puncture site.

  • If you received an AXIOS Stent, contact your doctor or hospital immediately with your lot number
  • Do not assume your stent is affected—your healthcare provider can confirm if yours is part of the recall
  • Keep your stent packaging or medical records handy to provide the lot number to your doctor
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
150 units
Manufactured in
100 Boston Scientific Way, N/A, Marlborough, MA, United States
Products
*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Material Number (UPN): M00553530;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1162-2026

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