Boston Scientific recalls WallFlex PC Esophageal Stent Systems (23/28mm x 155mm) due to potential catheter tip detachment during delivery. Affected units include specific lot numbers and model types.
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 (23/28mm x 155mm) because there's a risk of the delivery catheter tip detaching during insertion. This could lead to serious complications if the stent moves incorrectly in the esophagus.
The stent system uses a delivery catheter that could detach during insertion, potentially causing the stent to move incorrectly in the esophagus. This might lead to complications like injury to the esophagus or other internal structures.
Patients who have received the WallFlex PC Esophageal Stent System (23/28mm x 155mm) for esophageal strictures or fistulas are affected. Those with the specific lot numbers listed in the recall are at highest risk.
Check if your stent system has the model 'WallFlex PC Esophageal Stent 23/28mm x 155mm' and the listed lot numbers: 32764205, 32764206, 32827703, 32837016, 32837017, 32850357, 32869530, 32876613, 32891019, 32900187, 32938379, 33145977, 33160189, 33167134, 33242627.
Identify if your stent has the model 'WallFlex PC Esophageal Stent 23/28mm x 155mm' and one of the listed lot numbers.
The recall is due to the potential for delivery catheter tip detachment during insertion, which could cause the stent to move incorrectly in the esophagus.
Check your stent model and lot numbers against the list provided. If you have the affected model and lot numbers, contact Boston Scientific for further instructions.
Yes, the potential for catheter tip detachment could lead to complications such as esophageal injury if the stent moves incorrectly during insertion.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-3286-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-3286-2024 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.
