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FDA-Device2026-02-11Class IPROCESSING DEFECT

Boston Scientific AXIOS Stent 6mm x 8mm recalled for deployment and expansion issues

Boston Scientific
OTHERNationwide distribution

Contact your doctor about AXIOS Stent recall

Boston Scientific has recalled certain AXIOS Stents (6mm x 8mm) due to reports of problems with stent deployment and expansion during procedures. In some cases, the stent may not deploy properly, potentially requiring additional procedures to remove it and repair the site. No injuries have been reported.

  • If you received an AXIOS Stent procedure with the affected lot numbers, contact your healthcare provider immediately
  • Your doctor can verify whether your stent is affected and determine if monitoring or follow-up is needed
  • Do not delay seeking care if you experience unusual symptoms following your procedure
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
39 units
Manufactured in
100 Boston Scientific Way, N/A, Marlborough, MA, United States
Products
AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number (UPN): M00553680;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1159-2026

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