Device product
WALLFLEX ESOPHAGEAL FC 18/23-25MMX10CM- 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): M00516700
Z-3275-2024
Product summary
- Event
- Event 95124
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 231 units
- Official record key
device-enforcement:Z-3275-2024
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: 08714729778035 Lot Numbers: 32779260, 32790021, 32817917, 32860922, 32906415, 32966005, 32967262, 33026701, 33026703, 33077154, 33077157, 33085584 33147800, 33156072, 33218764, 33256093
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.