Boston Scientific recalls Wallflex Esophageal Stent Systems due to potential catheter tip detachment during delivery. Affected models include FC ESO STENT RMV 23X125MM. Stop using immediately if you own these stents.
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 delivery. This could cause serious injury if the stent moves incorrectly in the esophagus.
The catheter tip used to deliver the stent may detach during insertion. If the stent moves incorrectly in the esophagus, it could cause serious injury or death.
Patients with esophageal strictures or fistulas who received the recalled Wallflex stent systems are affected. Those who have the specific model numbers listed in the recall are most at risk.
Check for the model number FC ESO STENT RMV 23X125MM on the stent system packaging. The affected stents were sold with lot numbers including 32809368, 32846904, and others listed in the recall notice.
If you have the recalled Wallflex stent system, stop using it right away to prevent potential detachment.
The recalled model is Wallflex FC ESO STENT RMV 23X125MM for both Partially Covered (PC) and Fully Covered (FC) stent systems.
Check the model number on the packaging or the lot numbers listed in the recall: 32809368, 32846904, 32856377, 32867089, 32898068, 32908416, 32914771, 32919348, 32938992, 33058575.
Stop using it immediately and 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-3269-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-3269-2024 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.
