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FDA-Device2026-02-11Class IPROCESSING DEFECT

Boston Scientific HOT AXIOS Stent recalled for deployment and expansion issues

Boston Scientific
OTHERNationwide distribution

Check HOT AXIOS Stent lot numbers immediately

Boston Scientific's HOT AXIOS Stent (6mm × 8mm) may fail to deploy or expand properly during placement. If the stent does not expand correctly, patients may need additional endoscopic or surgical procedures to remove it and repair the puncture site.

  • Contact your healthcare provider if you received this device
  • Check the lot number on your device documentation against the FDA recall list
  • Do not use affected units; return them to Boston Scientific or your distributor
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
266 units
Manufactured in
100 Boston Scientific Way, N/A, Marlborough, MA, United States
Products
HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UPN): M00553520;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1161-2026

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