Boston Scientific recalls Wallflex Esophageal Stent Systems due to potential delivery catheter tip detachment. Affected units include specific model numbers and lot numbers. Consumers should contact 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 Esophage: Partially Covered and Fully Covered Stent Systems because the delivery catheter tip might detach during use. This could cause serious injury if the stent moves incorrectly in the esophagus.
The delivery catheter tip could detach during stent placement, which might cause the stent to move incorrectly in the esophagus. This could lead to injury if the stent shifts position or becomes lodged.
People who have the Wallflex Esophageal Stent System (model numbers and lot numbers listed) for esophageal strictures or fistulas are affected. Those with the specific model numbers and lot numbers from the recall list are most at risk.
Check for the model number M00516260 and lot numbers 32752366, 32752367, 32789716, 32919840, 32927193, 32956258, 32994874, or 33056529 on the product packaging.
Look for the model number M00516260 and lot numbers listed in the recall notice on the product packaging.
The delivery catheter tip could detach during stent placement, potentially causing the stent to move incorrectly in the esophagus.
Check for the model number M00516260 and lot numbers 32752366, 32752367, 32789716, 32919840, 32927193, 32956258, 32994874, or 33056529 on the product packaging.
The recall notice does not specify a remedy, so contact Boston Scientific for further instructions.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-3270-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-3270-2024 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.
