Ovation Prime Abdominal Stent Graft System — Class II medical device recall Z-1297-2014
Terminated recall by Trivascular, Inc, reported 2014-04-02. Communication to European physician users of the Ovation Prime Abdominal Stent Graft system to notify them of
| Recall number | Z-1297-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Trivascular, Inc, Santa Rosa, CA, United States |
| Recall initiated | 2014-02-27 |
| Classified | 2014-03-26 |
| Reported by FDA | 2014-04-02 |
| Terminated | 2014-04-11 |
| Countries outside the US | AT, BE, CZ, DE, ES, FR, GR, HU, IT, LU, NO, PL, SE |
| Quantity | 45 |
Product
Ovation Prime Abdominal Stent Graft System; Manufacturer: TriVascular, Inc. 3910 Brickway Blvd. Santa Rosa, CA 95403 The TriVascular Ovation Prime Abdominal Stent Graft System is an endovascular device delivered via a small diameter catheter to treat abdominal aortic aneurysms (AAAs). The stent graft is designed to reline the diseased vasculature, providing an endovascular blood conduit for isolating the aneurysm from the high pressure flow of blood, thereby reducing the risk of rupture. The stent graft is a modular configuration comprised of an aortic body section, iliac limbs, and iliac extensions as required.
Reason for recall
Communication to European physician users of the Ovation Prime Abdominal Stent Graft system to notify them of changes to Instructions for Use.
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-1297-2014. 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.