Boston Scientific recalls specific esophageal stent models due to potential delivery catheter tip detachment during procedures. Affected stents may cause serious injury if not properly secured.
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 certain esophageal stent systems that could detach during delivery, potentially causing serious injury. Patients using these stents should contact the company for guidance.
The stent system may cause the delivery catheter tip to detach during insertion, which could lead to serious injury if the detached catheter causes tissue damage or blockage.
Patients with esophageal strictures or fistulas who have received the recalled stent models are affected. Those undergoing procedures with these stents are at highest risk.
Check for the model name 'AGILE ESO OTW PC 23MM X 10.1CM IN 18.5 F' or 'AGILE Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System'. The product was sold with Material Number M00517720 and GTIN 00191506006594.
Reach out to Boston Scientific directly for specific guidance on whether your stent is affected and next steps.
The recall is due to potential delivery catheter tip detachment during insertion, which could cause serious injury.
The affected models are AGILE ESO OTW PC 23MM X 10.1CM IN 18.5 F and AGILE Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent Systems.
Check for the model name and the Material Number M00517720 or GTIN 00191506006594 on your stent packaging or documentation.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-3288-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-3288-2024 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.
