Boston Scientific recalls AGILE ESO OTW stents due to potential catheter tip detachment during delivery. Affected models include 23mm x 15.0cm in 18.5F size. Contact for return or repair 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 certain esophageal stents that may detach during delivery, potentially causing injury. This recall affects medical devices used to treat esophageal strictures from tumors or fistulas.
The stent delivery system could detach the catheter tip during insertion, which might cause injury to the esophagus. This risk occurs when the stent is being placed through the esophagus to treat narrowing caused by tumors or fistulas.
Patients with esophageal strictures from tumors or fistulas who use these stents are affected. Medical professionals performing procedures with these stents are at higher risk.
Check for the model name 'AGILE ESO OTW FC 23MM X 15.0CM IN 18.5 F' on the device. The product was sold with Material Number M00517780 and Lot Numbers 33266651.
Reach out to Boston Scientific directly for return or repair instructions as the recall remedy is not specified in the record.
The recalled stent is the AGILE ESO OTW FC 23MM X 15.0CM IN 18.5 F model.
Check for the model name 'AGILE ESO OTW FC 23MM X 15.0CM IN 18.5 F' on the device, and look for Material Number M00517780 or Lot Number 33266651.
The recall record does not specify a remedy, so contact Boston Scientific directly for return or repair 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-3292-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-3292-2024 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.
