Device product
WALLFLEX ESOPHAGEAL FC 23/28MMX15CM-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): M00516750
Z-3280-2024
Product summary
- Event
- Event 95124
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 516 units
- Official record key
device-enforcement:Z-3280-2024
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: 08714729778080 Lot Numbers: 32809369, 32809370, 32820234 ,32829719, 32837015, 32859849, 32888837, 32888838, 32914768, 32919658, 32919659, 32938991 32956256, 32977683, 32980850, 32986659, 32994875, 32998177, 33014830, 33101458, 33119730, 33176329, 33195046, 33195048 33208043, 33208044, 33218761, 33242625, 33266646, 33266649
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.