FDAFDA · Food and drugs·Recall number Z-3293-2024
AGILE ESO FC RMV 23MM X 6.2CM IN 18.5 FR-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas. Material Number (UPN): M00517790
Published October 2, 2024 · Recall initiated: August 1, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Boston Scientific Corporation
- Distributor
- Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.
- Lot
- GTIN: 00191506006662 Lot Numbers: 32889020, 33178844
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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