Boston Scientific recalls AXIOS Stent and Electrocautery-Enhanced Delivery System (20mm x 10mm) due to increased reports of deployment and expansion issues. The recall may require additional procedures to remove the stent if deployment fails.
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.
Boston Scientific is recalling its AXIOS Stent and Electrocautery-Enhanced Delivery System (20mm x 10mm) because it has caused deployment and expansion issues during procedures. If the stent cannot deploy properly, additional procedures may be needed to remove it and close the puncture site.
The stent may not deploy or expand correctly during procedures, leading to prolonged surgery. If the first flange fails to deploy, additional interventions like endoscopy or surgery may be required to remove the stent and close the puncture site.
Patients who have received this specific stent system during medical procedures are affected. Those with the recalled model (20mm x 10mm) are at risk of needing additional procedures if deployment fails.
Check for the product name 'AXIOS Stent and Electrocautery-Enhanced Delivery System' with the size 20mm x 10mm. The Material Number (UPN) is M00553660 or M00553680. Lot numbers listed in the recall include many specific numbers starting with 35961006 through 37844023.
Look for the product name 'AXIOS Stent and Electrocautery-Enhanced Delivery System' with size 20mm x 10mm and Material Numbers M00553660 or M00553680.
Boston Scientific reports increased issues with stent deployment and expansion during procedures. If the stent cannot deploy properly, additional procedures may be needed to remove it and close the puncture site.
Check if your stent matches the recalled model (20mm x 10mm) with Material Numbers M00553660 or M00553680. Contact your healthcare provider for guidance.
The recall does not provide a fix; it requires medical evaluation if deployment issues occur.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1158-2026 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1158-2026 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
