GORE¿ EXCLUDER¿ Iliac Branch Endoprosthesis — Class II medical device recall Z-0996-2020
Terminated recall by W. L. Gore & Associates Inc., reported 2020-02-12. Firm has received reports of leading end catheter component separations.
| Recall number | Z-0996-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | W. L. Gore & Associates Inc., Phoenix, AZ, United States |
| Recall initiated | 2020-01-06 |
| Classified | 2020-02-04 |
| Reported by FDA | 2020-02-12 |
| Terminated | 2022-08-09 |
| Countries outside the US | AE, AR, AT, AU, BR, CA, CH, CL, CN, CO, CR, CZ, DE, ES, FI, FR, GB, GR, HR, HU, IE, IL, IT, LB, MX, NL, NO, NZ, PA, PL, SA, SE, SI, TW |
| Quantity | 23,212 units |
Product
GORE¿ EXCLUDER¿ Iliac Branch Endoprosthesis (IBE)
Reason for recall
Firm has received reports of leading end catheter component separations.
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-0996-2020. 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.