Z-0125-2015 Class I Terminated
FDA device recall Z-0125-2015 was initiated by Trivascular, Inc on September 20, 2014 and is designated Class I. 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 du… The recall status is terminated (terminated December 4, 2014). Affected quantity: 0 Devices.
Recall Details
- Product Type
- Devices
- Report Date
- November 12, 2014
- Initiation Date
- September 20, 2014
- Termination Date
- December 4, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 0 Devices
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.
Distribution Pattern
International Distribution Only -- Canada, Turkey, Austria, Ireland, Belgium, Italy, Switzerland, Spain, France, and Cyprus.
Code Information
The devices subject to this action are labeled for distribution outside of the United States; therefore, no UDI is on the device label or package. Model Number: TV-AB2980-D Lot Numbers: FS031814-11 FS052214-22 FS052814-36 FS040414-21 FS050614-56 FS040714-53 FS040514-02 FS042614-05 FS050614-53 FS032614-46 FS050214-27 FS050314-12 FS052214-48 FS052214-53 FS031814-44 FS031814-49 FS032714-04 FS032714-20 FS040414-30 FS040514-08 FS050114-01 FS050114-08 FS050514-18 FS050514-27 FS050614-54 FS050614-55 FS051914-32 FS051914-34 Expiry dates ranging "May-17" through "Jun-17"