Boston Scientific recalls WallFlex PC Esophageal Stent Systems due to potential delivery catheter tip detachment. Affected units include specific lot numbers and model sizes. Consumers should contact for remedy.
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 that may have a delivery catheter tip that detaches during use. This could lead to serious complications if the stent becomes lodged in the esophagus.
The stent system's delivery catheter tip may detach during insertion, potentially causing the stent to become lodged in the esophagus. This could lead to serious complications such as blockage or injury to the esophagus.
Patients who have received the WallFlex PC Esophageal Stent System (23/28mm x 125mm) for esophageal strictures or fistulas are affected. Those who have undergone stent placement are most at risk.
Check for the WallFlex PC Esophageal Stent System (23/28mm x 125mm) with lot numbers listed in the recall notice. The product is used for esophageal strictures and fistulas.
Reach out to Boston Scientific for instructions on how to return or replace the stent system.
The WallFlex PC Esophageal Stent System (23/28mm x 125mm) is recalled.
Due to the potential for delivery catheter tip detachment during insertion, which could cause the stent to become lodged in the esophagus.
Check the lot numbers listed in the recall notice: 32759900, 32759903, 32789717, 32789718, 32829629, 32847692, 32848481, 32898067, 32919347, 32927195, 32949480, 32956257, 32957302, 32965072, 32985475, 32987961, 33047928, 33145976, 33145978, 33208046, 33208048, 33242626, 33275535.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-3285-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-3285-2024 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.
