Cook Inc. recalls Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL. The product is an endovascular graft.

Recall date

January 16, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1355-2020

FDA classification

Class II

Brand / firm

Cook Inc.

Sold / distributed

Foreign distribution only. Distributed worldwide.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL. The product is an endovascular graft.