Recall Z-0125-2015— Trivascular, Inc
Class I · Terminated
Class I FDA medical device recall by Trivascular, Inc, initiated 2014-09-20, terminated 2014-12-04. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..
- Recalling firm
- Trivascular, Inc
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2014-09-20
- Terminated
- 2014-12-04
- Firm location
- Santa Rosa, CA, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.