Trivascular, Inc
Trivascular, Inc appears in FDA public data with 3 recalls — including 1 Class I (most serious) —, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0125-2015, Class I) was initiated on September 20, 2014.
Summary
- Total Recalls
- 3 (1 Class I)
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0125-2015 | Class I | Ovation Prime Abdominal Stent Graft System - 29mm Aortic Body stent grafts. The TriVascular Ovati | September 20, 2014 |
| Z-1297-2014 | Class II | Ovation Prime Abdominal Stent Graft System; Manufacturer: TriVascular, Inc. 3910 Brickway Blvd. Sa | February 27, 2014 |
| Z-0288-2013 | Class II | TriVascular brand Fill Polymer Kit, Endovascular Graft, Aneurysm Treatment System, European Model Nu | October 19, 2012 |