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FDA-Device2026-02-11Class IPROCESSING DEFECT

Boston Scientific AXIOS Stent 8mm recalled for deployment and expansion issues

Boston Scientific
OTHERNationwide distribution

Contact your doctor about Boston Scientific AXIOS Stent

Boston Scientific is recalling certain AXIOS Stents (8mm x 8mm) used in medical procedures because they may not deploy or expand properly. If the stent fails to deploy correctly, additional procedures may be needed to remove it and repair the puncture site.

  • If you recently had a procedure using an AXIOS Stent 8mm, contact your doctor immediately.
  • Provide your doctor with the lot number from your procedure records if available.
  • Ask your doctor whether your stent was affected and whether follow-up care is needed.
  • Do not attempt to remove or adjust the stent yourself.
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
59 units
Manufactured in
100 Boston Scientific Way, N/A, Marlborough, MA, United States
Products
AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Material Number (UPN): M00553690;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1160-2026

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