Trivascular, Inc: Medical Device Recall in 2014 - (Recall #: Z-0125-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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).

Product Classification:

Class I

Date Initiated: September 20, 2014

Date Posted: November 12, 2014

Recall Number: Z-0125-2015

Event ID: 69326

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.

Status: Terminated

Product Quantity: 0 Devices

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"

Distribution Pattern:

International Distribution Only -- Canada, Turkey, Austria, Ireland, Belgium, Italy, Switzerland, Spain, France, and Cyprus.

Voluntary or Mandated:

Voluntary: Firm initiated