GORE CARDIOFORM ASD Occluder — Class II medical device recall Z-0136-2023
Ongoing recall by W L Gore & Associates, Inc., reported 2022-11-02, distributed nationwide. Due to manufacturing records (Release Test Results) indicating "Failed".
| Recall number | Z-0136-2023 |
|---|---|
| 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 | 2022-09-21 |
| Classified | 2022-10-26 |
| Reported by FDA | 2022-11-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | DK, JP |
| Quantity | 98 units |
| UPC / GTIN / UDI-DI | 00733132636501, 00733132636518, 00733132636617 |
| Serial numbers | 24281498, 24281499, 24281500, 24281501, 24281502, 24281503, 24281504, 24281505, 24281506, 24281507, 24281508, 24281509, 24281510, 24281511, 24281512, 24305079, 24305080, 24305081, 24305082, 24305083, 24429270, 24429271, 24429272, 24429273, 24429274 and 48 more |
| Model numbers | ASD37A, ASD44A, ASD44E |
Product
GORE CARDIOFORM ASD Occluder. cardiovascular implant.
Reason for recall
Due to manufacturing records (Release Test Results) indicating "Failed".
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-0136-2023. 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.