Boston Scientific recalls HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm (UPN M00553520) due to increased deployment and expansion issues. The recall may require additional procedures to remove the stent and close the puncture site.
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 have difficulty deploying or expanding properly during use. If the first flange fails to deploy, it could lead to additional interventions like endoscopic or surgical procedures to remove the stent and close the puncture site.
Medical professionals who use the recalled stent and delivery system for procedures. Patients who have received the recalled device are at risk of needing additional procedures.
The recalled product is the HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm with Material Number (UPN) M00553520. Lot numbers include 36067957 through 36917993 and other specific numbers listed in the recall notice.
Look for the lot numbers listed in the recall notice, which include 36067957 through 36917993 and other specific numbers.
Boston Scientific reports increased reports of stent deployment and expansion issues, which could lead to additional procedures to remove the stent and close the puncture site.
The recall does not specify a remedy, so contact Boston Scientific directly for guidance.
The recall states that the most serious outcome could be additional procedures to remove the stent and close the puncture site, but it does not mention injury.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1161-2026 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1161-2026 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.
