# FDA recall Z-2052-2020

> **W L Gore & Associates, Inc.** · Class II · device recall initiated 2019-12-17.

## Product

Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for endovascular repair of lesions of the descending thoracic aorta.

## Reason for recall

The incorrect label was placed on both the primary and secondary package.

## Distribution

International the country of Japan.

## Key facts

- **Recall number:** Z-2052-2020
- **Recalling firm:** W L Gore & Associates, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-12-17
- **Report date:** 2020-05-27
- **Termination date:** 2021-04-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Flagstaff, AZ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2052-2020

## Citation

> AI Analytics. FDA recall Z-2052-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2052-2020. Source: US FDA. Licensed CC0.

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