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 the company 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:al 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, potentially causing the stent to move incorrectly in the esophagus. This could lead to serious complications such as injury to the esophagus or other internal structures.
Patients with esophageal strictures or fistulas who have received the Wallflex stent system are affected. Those with the specific model numbers and lot numbers listed in the recall are most at risk.
Check the product label for the model number M00516240 and lot numbers 32867087, 32980849, 33014126, 33085585, 33128875, 33208047, 33233490, or 33275533. The stent system is intended for esophageal strictures or fistulas.
Look for the model number M00516240 and lot numbers listed in the recall.
The delivery catheter tip may detach during stent placement, potentially causing the stent to move incorrectly in the esophagus.
Check the product label for the model number M00516240 and lot numbers listed in the recall. Contact Boston Scientific for further instructions.
Yes, the potential for delivery catheter tip detachment could lead to serious complications if the stent moves incorrectly 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-3268-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-3268-2024 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.
