FDAFDA · Food and drugs·Recall number Z-3284-2024
WALLFLEX PC ESOPH STENT 23/28MM X 105MM- 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): M00516930
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: 08714729765271 Lot Numbers: 32770265, 32799938, 32799939 32809371, 32809372, 32957301 33128874, 33156073, 33156074 33156075, 33156076, 33233491 33233492
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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