Boston Scientific recalls HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm (UPN M00553530) due to increased stent deployment and expansion problems that may require additional procedures.
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 system for potential deployment issues that could lead to longer procedures or additional surgeries. This affects medical devices used in certain procedures, and users should check if their device matches the listed lot numbers.
The stent may have difficulty deploying or expanding properly, which can prolong the procedure and require exchanging the device. In severe cases, this might lead to additional endoscopic or surgical interventions to remove the stent and close the puncture site.
Medical professionals who use the HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm (UPN M00553530) are likely affected. Those performing procedures where stent deployment is critical are at higher risk.
Check if your device has the Material Number (UPN) M00553530 and lot numbers listed in the recall (e.g., 35985705, 35986358, etc.). The product is used in medical procedures and sold under the Boston Scientific brand.
Verify your device's Material Number (UPN) and lot numbers against the list provided in the recall.
Boston Scientific reports increased issues with stent deployment and expansion, which may lead to longer procedures or additional surgeries.
Check your device's Material Number (UPN) and lot numbers against the list provided in the recall. If it matches, contact Boston Scientific for further instructions.
The recall states that the most serious outcome could be additional interventions, but the remedy is not specified in the record.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1162-2026 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1162-2026 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
