FDA Device recall Z-1048-2023
GORE CARDIOFORM Septal Occluder, REF: GSX0030A
- FDA Device
- Class II
- ongoing
- Published 2023-02-08
On 2023-02-08 the FDA classified a Class II recall of GORE CARDIOFORM Septal Occluder, REF: GSX0030A by W L Gore And Associates, citing 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 failu….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1048-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-12-14 |
| Published | 2023-02-08 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | W L Gore And Associates |
| Distribution | US |
Product
GORE CARDIOFORM Septal Occluder, REF: GSX0030A
Reason
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.
Identifiers
| code_info | UDI-DI/Serial Numbers: 00733132631032/25556388, 25556389, 25556390, 25556391, 25556392, 25556393, 25556394, 25556398, 2…UDI-DI/Serial Numbers: 00733132631032/25556388, 25556389, 25556390, 25556391, 25556392, 25556393, 25556394, 25556398, 25556399, 25556400, 25556401, 25556402, 25556403, 25556406 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1048-2023%22
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