Ovation Prime Abdominal Stent Graft System - 29mm Aortic Body stent grafts. The TriVascular Ovation Prime Abdominal Sten
FDA device recall Z-0125-2015 · posted 2014-11-03 · Terminated
Recall details
- Recalling firm
- Trivascular, Inc
- 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.
- Action taken
- Urgent Field Safety Notice letter was sent to all consignees on 9/19/14 via trackable mail system. Users are notified that 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.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- MIH
- Quantity affected
- 0 Devices
- Distribution
- International Distribution Only -- Canada, Turkey, Austria, Ireland, Belgium, Italy, Switzerland, Spain, France, and Cyprus.
- Date initiated
- 2014-09-20
- Date posted
- 2014-11-03
- Date terminated
- 2014-12-04
- Location
- Santa Rosa, CA
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