Boston Scientific recalls certain Agile Esophageal Stents for potential catheter tip detachment during delivery, which could cause injury. Affected stents have specific model and lot numbers. Contact for return or replacement.
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 may detach during delivery, risking injury. This recall affects patients with esophageal strictures or fistulas who use these stents.
The stent system may cause the delivery catheter tip to detach during insertion. This detachment could lead to injury if the stent moves into the esophagus or other areas.
Patients with esophageal strictures or fistulas who use the recalled stents are most at risk. The recall applies to those who have received the specific model and lot numbers listed.
Check for the model name 'AGILE ESO FC RMV 23MM X 10.1CM IN 18.5 F' and lot number 33005087 on the product packaging.
Look for the model name 'AGILE ESO FC RMV 23MM X 10.1CM IN 18.5 F' and lot number 33005087 on the product packaging.
The stent system may cause the delivery catheter tip to detach during insertion, potentially leading to injury.
Check for the model name 'AGILE ESO FC RMV 23MM X 10.1CM IN 18.5 F' and lot number 33005087 on the product packaging.
The recall record does not specify a remedy, so contact Boston Scientific directly for guidance.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-3294-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-3294-2024 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.
