FDAFDA · Food and drugs·Recall number Z-3285-2024
WALLFLEX PC ESOPH STENT 23/28MM X 125MM- Wallflex Esophageal Partially Covered and Fully Covered 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): M00516940
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: 08714729765288 Lot Numbers: 32759900, 32759903, 32789717 32789718, 32829629, 32847692 32848481, 32898067, 32919347 32927195, 32949480, 32956257 32957302, 32965072, 32985475 32987961, 33047928, 33145976 33145978, 33208046, 33208048 33242626, 33275535
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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