Trivascular Recalls
3 recalls on record · November 21, 2012 to November 12, 2014 · Medical Devices
Recalls by year
12
14
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
November 12, 2014Medical DevicesFDA
Trivascular, Inc recalls Ovation Prime Abdominal Stent Graft System - 29mm Aortic Body stent grafts. The TriVascular Ovation Prime Abdominal S
Hazard: 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.
April 2, 2014Medical DevicesFDA
Trivascular, Inc recalls Ovation Prime Abdominal Stent Graft System; Manufacturer: TriVascular, Inc. 3910 Brickway Blvd. Santa Rosa, CA 95403
Hazard: Communication to European physician users of the Ovation Prime Abdominal Stent Graft system to notify them of changes to Instructions for Use.
November 21, 2012Medical DevicesFDA
Trivascular, Inc recalls TriVascular brand Fill Polymer Kit, Endovascular Graft, Aneurysm Treatment System, European Model Number: TVFP14-B, (in
Hazard: Selected lots of the Fill Polymer Kit (European Model Number: TVFP14- B) in European distributor inventory only that potentially contain leaking stopcocks due to possible cracks in the stopcock component. TriVascular indicated that these Fill Polymer Kits are for use with the Ovation or Ovation Prime Abdominal Stent Graft Systems that may display leaks upon initiation of mix but prior to use in