Boston Scientific recalls WallFlex PC Esophageal Stent Systems due to potential catheter tip detachment during delivery. Affected units have specific lot numbers and material codes. 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 WallFlex PC Esophageal Stent Systems because the delivery catheter tip might detach during insertion, which could cause injury. This recall affects specific lot numbers and model sizes.
The stent system uses a delivery catheter that could detach during insertion. If the catheter detaches, it might cause injury to the esophagus or surrounding tissues. This risk occurs during the procedure to place the stent.
Patients with esophageal strictures or fistulas who received the WallFlex PC stent system are affected. Those with the specific lot numbers listed in the recall are most at risk.
Check the product label for the material number M00516920 and GTIN 08714729765264. Affected units include lot numbers 32965060, 33077153, 33120914, and 33266650.
Look for the material number M00516920 and GTIN 08714729765264 on the stent system packaging.
Reach out to Boston Scientific for specific instructions on whether your stent is affected and next steps.
The WallFlex PC Esophageal Stent System with dimensions 18/23MM X 153MM is recalled.
Lot numbers 32965060, 33077153, 33120914, and 33266650 are affected.
The recall states there is a potential for delivery catheter tip detachment during insertion, which could cause injury.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-3283-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-3283-2024 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.
