Z-3266-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 2, 2024
- Initiation Date
- August 1, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 66 units
Product Description
WALLFLEX FC ESO STENT RMV 18X123MM-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System 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): M00516220
Reason for Recall
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.
Code Information
GTIN: 08714729854487 Lot Numbers: 33017652, 33213399, 33256089, 33275531