Ovation Prime Abdominal Stent Graft System — Class I medical device recall Z-0125-2015
Terminated recall by Trivascular, Inc, reported 2014-11-12. TriVascular has identified select lots of Ovation Prime 29mm Aortic Body stent grafts that may be associated w
| Recall number | Z-0125-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Trivascular, Inc, Santa Rosa, CA, United States |
| Recall initiated | 2014-09-20 |
| Classified | 2014-11-03 |
| Reported by FDA | 2014-11-12 |
| Terminated | 2014-12-04 |
| Countries outside the US | AT, BE, CA, CH, CY, ES, FR, IE, IT, TR |
| Quantity | 0 devices |
| Lot numbers | FS031814-11, FS031814-44, FS031814-49, FS032614-46, FS032714-04, FS032714-20, FS040414-21, FS040414-30, FS040514-02, FS040514-08, FS040714-53, FS042614-05, FS050114-01, FS050114-08, FS050214-27, FS050314-12, FS050514-18, FS050514-27, FS050614-53, FS050614-54, FS050614-55, FS050614-56, FS051914-32, FS051914-34, FS052214-22, FS052214-48, FS052214-53, FS052814-36 |
| Model numbers | TV-AB2980-D |
Product
Ovation Prime Abdominal Stent Graft System - 29mm Aortic Body stent grafts. The TriVascular Ovation Prime Abdominal Stent Graft System is a low-profile endovascular device delivered via catheter to treat descending abdominal aortic aneurysms (AAAs).
Reason for recall
TriVascular has identified select lots of Ovation Prime 29mm Aortic Body stent grafts that may be associated with rapid emptying of the fill polymer syringe when it is connected to the Autoinjector during the fill polymer injection step of the primary implant procedure.
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-0125-2015. 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.