Boston Scientific recalls WallFlex PC Esophageal Stent Systems due to potential delivery catheter tip detachment during procedures. Affected units include specific lot numbers and sizes. Contact for return instructions.
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 PC Esophageal Stent Systems that may have a delivery catheter tip that detaches during procedures. This could lead to serious complications if the stent becomes lodged in the esophagus.
The delivery catheter tip could detach during stent placement, potentially causing the stent to become lodged in the esophagus. This may lead to serious complications such as blockage or injury to the esophagus.
Patients who have undergone esophageal stent procedures using the recalled WallFlex PC Esophageal Stent Systems are most at risk. Healthcare providers using these devices for medical treatments may also be affected.
Check for the product name 'WallFlex PC Esophageal Stent System' with specific lot numbers listed in the recall notice. The stent size is 18/23mm x 103mm.
Reach out to Boston Scientific directly for instructions on returning the recalled stent system.
The recall is due to the potential for delivery catheter tip detachment during stent placement, which could cause the stent to become lodged in the esophagus.
The affected models are WallFlex PC Esophageal Stent Systems with sizes 18/23mm x 103mm and specific lot numbers listed in the recall notice.
Check the lot number on your stent system against the list of affected lot numbers provided in the recall notice.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-3281-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-3281-2024 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.
