Z-0125-2015Class I

Ovation Prime Abdominal Stent Graft System - 29mm Aortic Body stent grafts. The TriVascular Ovation Prime...

Name: Z-0125-2015 Ovation Prime Abdominal Stent Graft System - 29mm Aortic Body stent grafts. The TriVascular Ovation Prime...
Creator: Trivascular, Inc
Published: 2014-09-20
License: https://open.fda.gov/license/

Endologix LLC / initiated 2014-09-20 / Terminated

FDA source

Trivascular, Inc began a recall of Ovation Prime Abdominal Stent Graft System - 29mm Aortic Body stent grafts. The TriVascular Ovation Prime Abdominal Stent Graft System is a low-profile... on 2014-09-20. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0125-2015
Classification: Class I
Status: Terminated
Initiated: 2014-09-20
Posted: 2014-11-03
Terminated: 2014-12-04
Recalling firm: Endologix LLC
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).
Product code: MIH System, Endovascular Graft, Aortic Aneurysm Treatment
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.
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 0 Devices
Distribution: International Distribution Only -- Canada, Turkey, Austria, Ireland, Belgium, Italy, Switzerland, Spain, France, and Cyprus.
Product codes and lots: 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"

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0125-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0125-2015	Class I	Terminated	Voluntary: Firm initiated	2014-11-12	2014-11-03

Product code MIH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)