Cook Inc.: Medical Device Recall in 2020 - (Recall #: Z-1355-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: January 16, 2020

Date Posted: March 4, 2020

Recall Number: Z-1355-2020

Event ID: 84778

Reason for Recall:

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.

Status: Terminated

Product Quantity: 68,241

Code Information:

All lots. OUS distribution only; Product is not cleared or distributed in the USA.

Distribution Pattern:

Foreign distribution only. Distributed worldwide.

Voluntary or Mandated:

Voluntary: Firm initiated