Boston Scientific recalls certain esophageal stents for potential delivery catheter tip detachment. Affected stents include Agile ESO FC RMV 23MM X 15.0CM IN 18.5 F models with lot numbers 32889021 and 33178845.
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 may have a risk of delivery catheter tip detachment during medical procedures. This could potentially cause serious complications if the stent is used improperly.
The stent system may cause the delivery catheter tip to detach during insertion, which could lead to complications such as tissue injury or improper stent placement. This risk is specific to the medical procedure and not a general consumer hazard.
Patients who have been prescribed these specific esophageal stents for esophageal strictures or fistulas are affected. Medical professionals using the stents for treatment are also at risk.
Check for the model name 'AGILE ESO FC RMV 23MM X 15.0CM IN 18.5 F' on the stent packaging. Lot numbers 32889021 and 33178845 are associated with this recall.
Verify the model name and lot number on the stent packaging to determine if it is affected.
The recalled stents are the Agile ESO FC RMV 23MM X 15.0CM IN 18.5 F models.
Lot numbers 32889021 and 33178845 are affected.
The recall record does not specify a remedy.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-3295-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-3295-2024 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.
