Boston Scientific recalls certain esophageal stents that may detach during delivery, risking injury. Affected models include Agile ESO OTW FC 23mm x 10.1cm in 18.5F. Contact for return instructions.
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Boston Scientific is recalling specific esophageal stents that could detach during delivery, potentially causing injury. This recall affects medical devices used to treat esophageal strictures from tumors or fistulas.
The stent system has a risk of the delivery catheter tip detaching during insertion. This could cause the stent to move improperly, potentially leading to injury to the esophagus.
Patients receiving esophageal stents for strictures or fistulas from tumors are most at risk. Healthcare providers using these stents during procedures may also be affected.
Check for the model name 'Agile ESO OTW FC 23MM X 10.1CM IN 18.5 F' on the stent packaging. The product was sold with material number M00517760 and lot number 33005085.
Look for the model name 'Agile ESO OTW FC 23MM X 10.1CM IN 18.5 F' on the stent packaging or label.
Reach out to Boston Scientific directly for return or replacement instructions.
The recalled model is Agile ESO OTW FC 23MM X 10.1CM IN 18.5 F.
Check for the model name 'Agile ESO OTW FC 23MM X 10.1CM IN 18.5 F' on the packaging or label. The product was sold with material number M00517760 and lot number 33005085.
Contact Boston Scientific directly for return or replacement instructions.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-3291-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-3291-2024 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.
