# FDA recall Z-0048-2018

> **W L Gore & Associates, Inc.** · Class II · device recall initiated 2017-09-25.

## Product

GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE.     The GORE TAG Thoracic Endoprosthesis is intended  for endovascular repair of all lesions of the descending  thoracic aorta.

## Reason for recall

Incomplete and/or partial deployment of the CTAG Device during the endovascular procedure.

## Distribution

Worldwide.

## Key facts

- **Recall number:** Z-0048-2018
- **Recalling firm:** W L Gore & Associates, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-09-25
- **Report date:** 2017-11-01
- **Termination date:** 2019-08-27

- **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-0048-2018

## Citation

> AI Analytics. FDA recall Z-0048-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0048-2018. Source: US FDA. Licensed CC0.

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