# FDA recall Z-0290-2021

> **W L Gore & Associates, Inc.** · Class II · device recall initiated 2020-09-09.

## Product

GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System

## Reason for recall

Due to secondary deployment fiber being attached to secondary deployment handle, completion of deployment via the deployment line access hatch was not possible

## Distribution

U.S. - Nationwide    O.U.S. - Australia, Austria, Belgium, Croatia, Cypress, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Lebanon, Luxembourg, Monaco, Netherlands, Norway, New Zealand, Poland, Portugal, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom

## Key facts

- **Recall number:** Z-0290-2021
- **Recalling firm:** W L Gore & Associates, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-09-09
- **Report date:** 2020-11-04

- **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-0290-2021

## Citation

> AI Analytics. FDA recall Z-0290-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0290-2021. Source: US FDA. Licensed CC0.

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