# FDA recall Z-0136-2023

> **W L Gore & Associates, Inc.** · Class II · device recall initiated 2022-09-21.

## Product

GORE CARDIOFORM ASD Occluder. cardiovascular implant.

## Reason for recall

Due to manufacturing records (Release Test Results) indicating "Failed".

## Distribution

Worldwide distribution - U.S. Nationwide distribution including in the states of AZ, CA, CO, DC, FL, GA, IA, ID, IL, ME, MN, NC, NY, JPA, TN, TX, WA, and WI. The countries of Denmark, and Japan.

## Key facts

- **Recall number:** Z-0136-2023
- **Recalling firm:** W L Gore & Associates, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-09-21
- **Report date:** 2022-11-02

- **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-0136-2023

## Citation

> AI Analytics. FDA recall Z-0136-2023. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-0136-2023. Source: US FDA. Licensed CC0.

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