# FDA recall Z-1048-2023

> **W L Gore & Associates, Inc.** · Class II · device recall initiated 2022-12-14.

## Product

GORE CARDIOFORM Septal Occluder, REF: GSX0030A

## Reason for recall

Septal Occluders released with incomplete quality test documentation that assesses the release of the device from the delivery system during the index procedure. A potential failure of this quality test could potentially result could result in occluder embolization, anoxic brain injury, central venous or arterial perforation or rupture.

## Distribution

US Nationwide distribution in the states of NY, CA, FL, CT, TX, AR, IN, MA, MO, SD, VA.

## Key facts

- **Recall number:** Z-1048-2023
- **Recalling firm:** W L Gore & Associates, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-12-14
- **Report date:** 2023-02-08

- **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-1048-2023

## Citation

> AI Analytics. FDA recall Z-1048-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1048-2023. Source: US FDA. Licensed CC0.

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