Boston Scientific recalls WallFlex FC ESO stent systems due to potential catheter tip detachment during delivery. Affected units have specific lot numbers and material codes. Consumers should contact for remedy 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 WallFlex FC ESO stent systems that could detach during delivery, risking injury. This recall affects specific lot numbers and model types used for esophageal strictures.
The stent system's delivery catheter tip could detach during insertion, potentially causing injury to the esophagus. This risk occurs when the stent is being placed through the esophagus to treat strictures or fistulas.
Patients with esophageal strictures or fistulas who received the WallFlex FC ESO stent system are affected. Those with specific lot numbers (33017652, 33213399, 33256089, 33275531) are most at risk.
Check for the model name 'WallFlex FC ESO STENT RMV 18X123MM' and lot numbers 33017652, 33213399, 33256089, or 33275531. The product is used for esophageal strictures and fistulas.
Reach out to Boston Scientific directly for specific remedy instructions as the recall record does not provide a remedy.
The recall is due to potential delivery catheter tip detachment during stent insertion, which could cause esophageal injury.
Lot numbers 33017652, 33213399, 33256089, and 33275531 are affected.
The recall record does not specify a stop-use instruction, so continue using as directed but contact Boston Scientific for remedy details.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-3266-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-3266-2024 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.
