Boston Scientific recalls AXIOS 8mm x 8mm stent systems with material number M00553690 due to deployment problems that may require additional procedures. Affected units include specific lot numbers.
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 8mm x 8mm stent and delivery system because it can have trouble deploying properly. This might cause the procedure to take longer or require additional surgery to fix the issue.
The stent may not deploy correctly, which could lead to the procedure taking longer or requiring additional surgery to remove the stent and close the puncture site. This happens most often when the first flange can't expand properly.
Patients who have received the recalled stent system during a procedure are affected. Those with the specific lot numbers listed in the recall are most at risk.
Check the material number (UPN) M00553690 on the device. Affected units include specific lot numbers listed in the recall notice.
Look for the material number (UPN) M00553690 and specific lot numbers listed in the recall.
Boston Scientific reports increased issues with stent deployment, which may cause procedures to take longer or require additional surgery to fix.
Check the material number (UPN) M00553690 and specific lot numbers listed in the recall to see if your device is affected.
The recall does not mention a fix or remedy; affected devices should be checked against the listed lot numbers.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1160-2026 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1160-2026 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.
