Boston Scientific recalls WallFlex FC ESO stent systems due to potential catheter tip detachment during delivery. Affected units include specific model and lot numbers. 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 FC ESO stent systems that may have a catheter tip that detaches during delivery. This could cause serious injury if the stent moves into the esophagus or airway. Affected units have specific model and lot numbers.
The stent system's delivery catheter tip may detach during insertion, potentially causing the stent to move into the esophagus or airway. This could lead to injury if the stent becomes lodged or moves unexpectedly.
Patients with esophageal strictures or fistulas who received the WallFlex FC ESO stent system. Those with the specific model and lot numbers are most at risk.
Check for the model name 'WallFlex FC ESO STENT RMV 18X153MM' and lot numbers starting with 33094174. The product was sold with specific material number (UPN) M00516230 and GTIN 08714729854494.
Reach out to Boston Scientific directly for specific instructions on how to verify your product and get replacement or repair options.
The recall is due to the potential for delivery catheter tip detachment, which could cause the stent to move into the esophagus or airway, leading to injury.
The affected model is WallFlex FC ESO STENT RMV 18X153MM, with lot numbers starting with 33094174.
Check for the model name 'WallFlex FC ESO STENT RMV 18X153MM' and lot numbers starting with 33094174. The product also has material number UPN M00516230 and GTIN 08714729854494.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-3267-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-3267-2024 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.
