GORE CARDIOFORM Septal Occluder — Class II medical device recall Z-1048-2023
Ongoing recall by W L Gore & Associates, Inc., reported 2023-02-08, distributed nationwide. Septal Occluders released with incomplete quality test documentation that assesses the release of the device f
| Recall number | Z-1048-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | W L Gore & Associates, Inc., Flagstaff, AZ, United States |
| Recall initiated | 2022-12-14 |
| Classified | 2023-02-01 |
| Reported by FDA | 2023-02-08 |
| Distributed | Nationwide (US) |
| Quantity | 14 |
| UPC / GTIN / UDI-DI | 00733132631032 |
| Serial numbers | 00733132631032/25556388, 25556389, 25556390, 25556391, 25556392, 25556393, 25556394, 25556398, 25556399, 25556400, 25556401, 25556402, 25556403, 25556406 |
| Model numbers | GSX0030A |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1048-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.