# FDA recall Z-1355-2020

> **Cook Inc.** · Class II · device recall initiated 2020-01-16.

## Product

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

## 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.

## Distribution

Foreign distribution only. Distributed worldwide.

## Key facts

- **Recall number:** Z-1355-2020
- **Recalling firm:** Cook Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-01-16
- **Report date:** 2020-03-04
- **Termination date:** 2020-11-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bloomington, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1355-2020

## Citation

> AI Analytics. FDA recall Z-1355-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1355-2020. Source: US FDA. Licensed CC0.

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