Device product
WALLFLEX PC ESOPH STENT 18/23MM X 153MM- 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): M00516920
Z-3283-2024
Product summary
- Event
- Event 95124
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 39 units
- Official record key
device-enforcement:Z-3283-2024
Official wording
Reason: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Code information: GTIN: 08714729765264 Lot Numbers: 32965060, 33077153, 33120914, 33266650
Distribution pattern: Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.
Derived failure modes
-
Unknown
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.