Drug recall
Ovation Prime Abdominal Stent Graft System - 29mm Aortic Body stent grafts. The TriVascular Ovation Prime…
FDA recall event 69326 · Class I · Trivascular, Inc
Key facts
| Event ID | 69326 |
|---|---|
| Recall numbers | Z-0125-2015 |
| Recalling firm | Trivascular, Inc |
| Product type | Devices |
| Products | 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… |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Sep 20, 2014 |
| Report date | Nov 12, 2014 |
| Termination date | Dec 4, 2014 |
| City | Santa Rosa |
| State | CA |
| Country | United States |
| FEI number | 3008011247 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: