Boston Scientific recalls HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm (UPN M00553560) due to increased reports of stent deployment and expansion problems.
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 a specific stent and delivery system for potential deployment issues. If the stent cannot deploy properly, it may require additional procedures to remove it and close the puncture site.
The stent may not deploy or expand correctly, leading to prolonged procedures. In severe cases, this could require additional endoscopic or surgical steps to remove the stent and close the puncture site.
Medical professionals who use this stent system during procedures are most at risk. Patients who have received this device may need additional interventions.
Check for the Material Number (UPN) M00553560 on the device. The product was sold with specific lot numbers listed in the recall notice.
Identify the Material Number (UPN) M00553560 and lot numbers listed in the recall notice.
The recall reports increased reports of deployment issues, but the device is not inherently dangerous. The risk is related to potential deployment problems during use.
The recall does not specify a remedy, so contact Boston Scientific directly for guidance.
Look for the Material Number (UPN) M00553560 and check the lot numbers listed in the recall notice.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1163-2026 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1163-2026 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.
