Device product
Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL. The product is an endovascular graft.
Z-1355-2020
Product summary
- Firm
- Cook Inc.
- Event
- Event 84778
- Status
- Terminated
- Classification
- Class II
- Quantity
- 68,241
- Official record key
device-enforcement:Z-1355-2020
Official wording
Reason: The firm has identified factors which contributed to failures relating to thrombus formation and/or lumen occlusion reports, and is highlighting to customers key points of the IFU pertaining to the prevention of these factors. In addition, the firm has updated the Planning and Sizing Worksheet to include associated information.
Code information: All lots. OUS distribution only; Product is not cleared or distributed in the USA.
Distribution pattern: Foreign distribution only. Distributed worldwide.
Derived failure modes
-
Unknown
The firm has identified factors which contributed to failures relating to thrombus formation and/or lumen occlusion reports, and is highlighting to customers key points of the IFU pertaining to the prevention of these factors. In addition, the firm has updated the Planning and Sizing Worksheet to include associated information.