Boston Scientific recalls certain AGILE esophageal stents due to potential delivery catheter tip detachment. Affected models include RMV 23MM X 6:2CM IN 18.5 FR. Owners should contact for remedy 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 specific esophageal stents that could detach during delivery, potentially causing injury. This recall affects medical devices used to treat esophageal strictures from tumors or fistulas.
The delivery catheter tip may detach during stent insertion, which could cause injury to the esophagus. This risk occurs when the stent is being placed through the esophagus.
Patients receiving esophageal stents for strictures from tumors or fistulas. Medical professionals using these stents during procedures are most at risk.
Check for the model name 'AGILE ESO FC RMV 23MM X 6.2CM IN 18.5 FR' on the stent packaging. The lot numbers 32889020 and 33178844 are also associated with this recall.
Reach out to Boston Scientific for specific instructions on how to return or replace the stent.
The recalled stents are AGILE ESO FC RMV 23MM X 6.2CM IN 18.5 FR.
The delivery catheter tip may detach during insertion, potentially causing esophageal injury.
Look for the model name 'AGILE ESO FC RMV 23MM X 6.2CM IN 18.5 FR' on the packaging or lot numbers 32889020 and 33178844.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-3293-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-3293-2024 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.
