Device product
WALLFLEX PC ESOPH STENT 18/23MM X 123MM- 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): M00516910
Z-3282-2024
Product summary
- Event
- Event 95124
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 308 units
- Official record key
device-enforcement:Z-3282-2024
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: 08714729765257 Lot Numbers: 32780161, 32827704, 32875120, 32876612, 32915744, 32946076, 32967272, 32967273, 33014124, 33030431, 33045961, 33077152 33128873, 33146800, 33176330, 33195047, 33226266, 33233489, 33256090, 33256091
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.