Boston Scientific recalls Wallflex Esophageal Stent Systems due to potential delivery catheter tip detachment. Affected models include FC ESO STENT RMV LL 18X1:103. Consumers should contact for remedy 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 Esophageal Stent Systems that may have a delivery catheter tip that can detach during use. This could lead to serious complications if the stent moves incorrectly in the esophagus.
The delivery catheter tip may detach during stent placement or removal. If the stent moves incorrectly in the esophagus, it could cause injury or blockage.
People who have a Wallflex Esophageal Stent System for esophageal strictures or fistulas. Those with medical conditions requiring stent placement are most at risk.
Check for the model number M00516270 with lot numbers 32837018, 32946075, 33014125, or 33218762. The product is for esophageal strictures or fistulas.
Reach out to Boston Scientific for specific remedy instructions as the recall record does not provide a remedy.
The Wallflex FC ESO STENT RMV LL 18X103 with material number M00516270 and specific lot numbers.
Due to the potential for delivery catheter tip detachment during stent placement or removal, which could cause injury.
The recall record does not specify a remedy; consumers should contact Boston Scientific for 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-3271-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-3271-2024 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
