Boston Scientific recalls Wallflex FC ESO stent systems due to potential catheter tip detachment during esophageal stent placement. Affected units have specific lot numbers and material codes. 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 FC ESO stent systems that may have a catheter tip that detaches during use, potentially causing serious injury. This recall affects specific lot numbers and model types used for treating esophageal strictures.
The stent system may cause the delivery catheter tip to detach during insertion. This could lead to the stent moving into the esophagus or causing injury to the esophagus. The detachment risk is highest during the procedure when the stent is being placed.
Patients with esophageal strictures or fistulas who received the Wallflex FC ESO stent system from Boston Scientific are affected. Those who had the specific lot numbers listed in the recall are most at risk.
Check for the model name 'Wallflex FC ESO STENT RMV 18X103MM' and lot numbers 33045962, 33120912, 33137308, 33208045, or 33245087. The product is intended for esophageal strictures and fistulas.
Identify your stent model and lot numbers by checking the product label or documentation.
Reach out to Boston Scientific for specific return or repair instructions based on your product details.
The hazard is the potential for the delivery catheter tip to detach during insertion, which could cause injury to the esophagus.
Affected lot numbers are 33045962, 33120912, 33137308, 33208045, and 33245087.
No, but you should contact Boston Scientific to get specific instructions based on your product details.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-3265-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-3265-2024 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.
