Boston Scientific recalls WallFlex Esophageal Stent Systems with potential catheter tip detachment. Affected units include specific lot numbers and model codes. Stop using immediately to prevent injury.
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 Esophageal Stent Systems that may have a catheter tip that detaches during use. This could lead to serious injury if the stent moves in the esophagus. Affected units have specific lot numbers and model codes.
The stent system may cause the delivery catheter tip to detach during insertion. If the catheter detaches, it could move within the esophagus and cause injury, such as a blockage or perforation.
Patients who have received the WallFlex Esophageal Stent System for esophageal strictures or fistulas are affected. Those with the specific lot numbers listed in the recall are at the highest risk.
Check the product label for the model code M00516740 and lot numbers listed in the recall (e.g., 32771050, 32771051). The stent system is intended for esophageal strictures or fistulas.
Discontinue use of the WallFlex Esophageal Stent System if you have the affected lot numbers listed in the recall.
The WallFlex Esophageal FC 23/28MMX12CM stent system with model code M00516740.
Lot numbers 32771050, 32771051, 32789719, 32790020, 32827713, 32837013, 32837014, 32846903, 32856378, 32875122, 32876614, 32888839, 32906418, 32914770, 32919349, 32927196, 32928279, 32938993, 33014831, 33038108, 33101459, 33102100, 33119729, 33137310, 33137311, 33137312, 33145979, 33176328, 33218760, 33256094, 33266648.
The recall is due to the potential for the delivery catheter tip to detach during insertion, which could cause injury if the stent moves in the esophagus.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-3279-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-3279-2024 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.
