Boston Scientific recalls AXIOS Stent and Electrocautery-Enhanced Delivery System (6mm x 8mm) due to deployment issues that may require additional procedures. Affected units have specific material numbers and 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 Stent and Electrocautery-Enhanced Delivery System (6mm x 8mm) because it can have trouble deploying properly. This may lead to longer procedures to replace the device or additional surgeries to remove the stent and close the puncture site.
The stent may not deploy correctly, causing the procedure to take longer and requiring a device exchange. In severe cases, this could lead to additional surgeries to remove the stent and close the puncture site.
Medical professionals who use the AXIOS Stent system for procedures are most at risk. Patients who have received this device during a procedure may need additional interventions.
Check for the Material Number (UPN) M00553680 or Lot Numbers listed in the recall notice. The product is used in medical procedures and sold with specific identifiers.
Review the Material Number (UPN) and Lot Numbers provided in the recall notice to confirm if your device is affected.
The recall addresses potential deployment issues that may require additional procedures, but the risk of serious injury is not explicitly stated in the notice.
Check the Material Number (UPN) and Lot Numbers listed in the recall notice to determine if your device is affected.
Look for the Material Number (UPN) M00553680 or Lot Numbers from the list provided 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-1159-2026 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1159-2026 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.
