Device product
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
Z-3285-2024
Product summary
- Event
- Event 95124
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 305 units
- Official record key
device-enforcement:Z-3285-2024
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: 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
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.