Boston Scientific recalls specific esophageal stent models for potential catheter tip detachment during delivery, which could cause serious injury. Affected units include Agile ESO OTW PC 23MM X 15.0CM IN 18.5 F models with material number M00517740.
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 certain esophageal stent models because there's a risk of the delivery catheter tip detaching during use. This could lead to serious injury if the stent moves incorrectly in the esophagus.
The delivery catheter tip could detach during stent placement, potentially causing the stent to move into the esophagus or airway. This might lead to serious injury if the stent becomes lodged or causes tissue damage.
Patients who have received the specific Agile ESO OTW stent models for esophageal strictures or fistulas are affected. Those with the listed material number or lot numbers are most at risk.
Check for the model name 'Agile ESO OTW PC 23MM X 15.0CM IN 18.5 F' on the stent packaging. The material number M00517740 and lot number 33005084 are also associated with this recall.
Identify the model name on the stent packaging to confirm if it matches the recalled Agile ESO OTW PC 23MM X 15.0CM IN 18.5 F.
Reach out to Boston Scientific directly for guidance on next steps if you have the recalled stent model.
The recalled model is Agile ESO OTW PC 23MM X 15.0CM IN 18.5 F.
Check for the model name 'Agile ESO OTW PC 23MM X 15.0CM IN 18.5 F' on the packaging, and look for material number M00517740 or lot number 33005084.
Contact Boston Scientific directly for guidance on next steps, as the recall remedy is not specified in the record.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-3290-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-3290-2024 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.
