Ovation iX Abdominal Stent Graft Systems — Class I medical device recall Z-2263-2020
Terminated recall by Endologix, Inc., reported 2020-06-17, distributed nationwide. A material weakness adjacent to the polymer fill channel may become compromised during pressurization with liq
| Recall number | Z-2263-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Endologix, Inc., Santa Rosa, CA, United States |
| Recall initiated | 2020-05-06 |
| Classified | 2020-06-10 |
| Reported by FDA | 2020-06-17 |
| Terminated | 2024-05-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, CA, CH, CL, CY, CZ, DE, ES, GB, HK, HU, IE, IT, JP, LU, MX, MY, NL, NZ, PL, PT, RO, SE, TH, TW |
| Quantity | 9,156 |
| Reason classes | packaging |
| Model numbers | TV-AB2080-I, TV-AB2080-J, TV-AB2380-I, TV-AB2380-J, TV-AB2680-I, TV-AB2680-J, TV-AB2980-I, TV-AB2980-J, TV-AB3480-I, TV-AB3480-J |
Product
Ovation iX Abdominal Stent Graft Systems, REF: TV-AB2080-I, TV-AB2080-J, TV-AB2380-I, TV-AB2380-J, TV-AB2680-I, TV-AB2680-J, TV-AB2980-I, TV-AB2980-J, TV-AB3480-I, TV-AB3480-J
Reason for recall
A material weakness adjacent to the polymer fill channel may become compromised during pressurization with liquid polymer. Polymer leaks may occur during implantation of abdominal stent graft system. Clinical events related to polymer leaks may be systemic and/or aneurysm related.
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-2263-2020. 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.