Boston Scientific recalls WallFlex PC Esophageal Stent Systems due to potential delivery catheter tip detachment. Affected models include specific lot numbers and sizes. 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 use, which could cause serious injury. This recall affects specific model sizes and lot numbers sold to patients needing esophageal stents for strictures or fistulas.
The delivery catheter tip could detach during stent placement, potentially causing injury to the esophagus or other internal structures. This risk occurs when the stent is being inserted through the esophagus to treat narrowings or blockages.
Patients with esophageal strictures or fistulas who received the WallFlex PC Esophageal Stent System (18/23mm x 123mm) from specific lot numbers are affected. Those who have the stent and are undergoing treatment are most at risk.
Check the product label for the model size 18/23mm x 123mm and lot numbers listed: 32780161, 32827704, 32875120, 32876612, 32915744, 32946076, 32967272, 32967273, 33014124, 33030431, 33045961, 33077152, 33128873, 33146800, 33176330, 33195047, 33226266, 33233489, 33256090, 33256091.
Reach out to Boston Scientific directly to confirm if your stent is affected and get instructions for next steps.
The recall states there is a potential for delivery catheter tip detachment, which could cause injury. Do not use the stent until you contact Boston Scientific for guidance.
Contact Boston Scientific to determine if your specific lot number is affected and follow their instructions.
Check the product label for the model size 18/23mm x 123mm and lot numbers listed in the recall notice.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-3282-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-3282-2024 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.
