# FDA recall Z-0291-2021

> **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

When the delivery catheter was attempted to be removed, there was an observed connection between the stent graft and the delivery catheter that prevented the delivery catheter from being withdrawn.

## 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-0291-2021
- **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-0291-2021

## Citation

> AI Analytics. FDA recall Z-0291-2021. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-0291-2021. Source: US FDA. Licensed CC0.

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