Boston Scientific recalls WallFlex Esophageal Stent Systems due to potential catheter tip detachment during delivery. Affected models include 18/23-25mmx12cm. 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 Esophageal Stent Systems that may detach during delivery, risking injury. This recall affects specific model sizes and lot numbers. The hazard could cause serious injury if the catheter detaches during insertion.
The delivery catheter tip could detach during stent insertion, potentially causing injury to the esophagus. This risk occurs when the stent is being placed through the esophagus.
Patients with esophageal strictures or fistulas who use these stents are most at risk. Medical professionals who have the affected models in their inventory may also be affected.
Check for the model number 18/23-25mmx12cm on the stent system packaging. Affected lot numbers include 32779261, 32820237, 32906416, 33030432, 33077155, 33077156, 33094173, 33137309, 33137313, 33195043.
Reach out to Boston Scientific for specific instructions on how to handle the recalled stent system.
The delivery catheter tip could detach during stent insertion, potentially causing esophageal injury.
WallFlex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent Systems with model 18/23-25mmx12cm.
Check the model number on the packaging and compare with the listed lot numbers: 32779261, 32820237, 32906416, 33030432, 33077155, 33077156, 33094173, 33137309, 33137313, 33195043.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-3276-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-3276-2024 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.
