Boston Scientific recalls certain AGILE esophageal stents due to potential catheter tip detachment during delivery. Affected stents have specific model and lot numbers. Consumers should contact the company for details.
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, potentially causing injury. This recall affects patients with esophageal strictures or fistulas who received these stents.
The stent system may cause the delivery catheter tip to detach during insertion. This could lead to complications such as esophageal injury or blockage if the stent moves unexpectedly.
Patients with esophageal strictures or fistulas who received the recalled stents are most at risk. The recall applies to specific model and lot numbers of the AGILE stent system.
Check for the model name 'AGILE ESO OTW PC 23MM X 12.0CM IN 18.5 F' and lot numbers starting with 33005086. The stents are used for esophageal strictures or fistulas.
Reach out to Boston Scientific directly for specific instructions on how to handle the recalled stent.
The potential for delivery catheter tip detachment during insertion, which could cause esophageal injury.
Contact Boston Scientific directly for specific instructions on handling the recalled stent.
The affected model is AGILE ESO OTW PC 23MM X 12.0CM IN 18.5 F with lot numbers starting with 33005086.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-3289-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-3289-2024 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.
