FDA-Device2020-03-04Class II
Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL. The product is an endovascular graft.
Cook Inc.
Hazard
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.
Sold states
Foreign distribution only. Distributed worldwide.
Affected count
68,241
Manufactured in
750 N Daniels Way, N/A, Bloomington, IN, United States
Products
Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL. The product is an endovascular graft.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1355-2020Don't want to check this manually?
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