Z-1297-2014Class II

Ovation Prime Abdominal Stent Graft System; Manufacturer: TriVascular, Inc. 3910 Brickway Blvd. Santa Rosa...

Name: Z-1297-2014 Ovation Prime Abdominal Stent Graft System; Manufacturer: TriVascular, Inc. 3910 Brickway Blvd. Santa Rosa...
Creator: Trivascular, Inc
Published: 2014-02-27
License: https://open.fda.gov/license/

Endologix LLC / initiated 2014-02-27 / Terminated / root cause: design

FDA source

Trivascular, Inc began a recall of Ovation Prime Abdominal Stent Graft System; Manufacturer: TriVascular, Inc. 3910 Brickway Blvd. Santa Rosa, CA 95403 The TriVascular Ovation Prime Abdominal... on 2014-02-27. FDA classified it as Class II and gives the reason as "Communication to European physician users of the Ovation Prime Abdominal Stent Graft system to notify them of changes to Instructions for Use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1297-2014
Classification: Class II
Status: Terminated
Initiated: 2014-02-27
Posted: 2014-03-26
Terminated: 2014-04-11
Recalling firm: Endologix LLC
Product: Ovation Prime Abdominal Stent Graft System; Manufacturer: TriVascular, Inc. 3910 Brickway Blvd. Santa Rosa, CA 95403 The TriVascular Ovation Prime Abdominal Stent Graft System is an endovascular device delivered via a small diameter catheter to treat abdominal aortic aneurysms (AAAs). The stent graft is designed to reline the diseased vasculature, providing an endovascular blood conduit for isolating the aneurysm from the high pressure flow of blood, thereby reducing the risk of rupture. The stent graft is a modular configuration comprised of an aortic body section, iliac limbs, and iliac extensions as required.
Product code: MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Reason for recall: Communication to European physician users of the Ovation Prime Abdominal Stent Graft system to notify them of changes to Instructions for Use.
Root cause tag: design
FDA root cause: Device Design
Action: Trivascular sent an Important Medical Device Information letter dated February 27, 2014, to all European physicians who have scheduled cases through March 31, 2014 or until IFU;s are translated and available for European physicians. The letter provided notification of an update that will appear in a future revision of the product Instructions for Use (IFU). The IFU will be available in their country when the required translations and product registration/notification have been completed. This IFU does not require rework or return of the affected product. Customers with questions were instructed to contact their local TriVascular representative. For questions regarding this recall call 707-543-8805.
Quantity in commerce: 45
Distribution: Worldwide Distribution including Austria, Belgium, Czech Republic, France, Germany, Greece, Hungary, Italy, Luxembourg, Norway, Poland, Spain, and Sweden.
Product codes and lots: All codes

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1297-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1297-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-02	2014-03-26

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)