# FDA recall Z-0995-2020

> **W. L. Gore & Associates Inc.** · Class II · device recall initiated 2020-01-06.

## Product

GORE¿ EXCLUDER¿ AAA Endoprosthesis

## Reason for recall

Firm has received reports of leading end catheter component separations.

## Distribution

US:    OUS: Australia; Austria; Canada; China; Taiwan; United Arab Emirates; Argentina; Brazil; Switzerland; Chile; Colombia; Costa Rica; Czechia; Spain; Greece; Croatia; Hungary; Ireland; Israel; Italy; United Kingdom; Lebanon; Mexico; New Zealand; Panama; Poland; Saudi Arabia; Slovenia; Germany; Netherlands; Norway; Finland; France; Sweden; Monaco;

## Key facts

- **Recall number:** Z-0995-2020
- **Recalling firm:** W. L. Gore & Associates Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-01-06
- **Report date:** 2020-02-12
- **Termination date:** 2022-08-09

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0995-2020

## Citation

> AI Analytics. FDA recall Z-0995-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0995-2020. Source: US FDA. Licensed CC0.

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