Boston Scientific recalls Agile Esophageal Stents (M0051771: 23mm x 6.2cm) for potential delivery catheter tip detachment during procedures. Affected units include specific lot numbers and model types.
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 stents that may detach the delivery catheter during procedures. This could lead to serious complications if the stent moves incorrectly in the esophagus.
The delivery catheter tip may detach during stent placement, potentially causing the stent to move incorrectly in the esophagus. This could lead to serious complications such as injury to the esophagus or airway.
Patients who have received the specific Agile Esophageal Stent models (PC or FC) for esophageal strictures or fistulas are affected. Medical professionals using these stents during procedures are at risk.
Check for the model name 'Agile Esophageal Partially Covered (PC) or Fully Covered (FC) OTW Stent System' with the specific size (23mm x 6.2cm). The product has a Material Number (UPN) of M00517710 and GTIN 00191506006587.
Identify the model and size (23mm x 6.2cm) and check the Material Number (UPN) M00517710.
Reach out to Boston Scientific for further guidance on the recall and potential next steps.
The recalled stents are Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stents with a size of 23mm x 6.2cm.
The recall is due to the potential for delivery catheter tip detachment during stent placement, which could cause serious complications.
Check for the model name 'Agile Esophageal Partially Covered (PC) or Fully Covered (FC) OTW Stent System' with the specific size (23mm x 6.2cm) and Material Number (UPN) M00517710.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-3287-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-3287-2024 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.
