Z-1297-2014 Class II Terminated
FDA device recall Z-1297-2014 was initiated by Trivascular, Inc on February 27, 2014 and is designated Class II. 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. The recall status is terminated (terminated April 11, 2014). Affected quantity: 45.
Recall Details
- Product Type
- Devices
- Report Date
- April 2, 2014
- Initiation Date
- February 27, 2014
- Termination Date
- April 11, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 45
Product Description
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.
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.
Distribution Pattern
Worldwide Distribution including Austria, Belgium, Czech Republic, France, Germany, Greece, Hungary, Italy, Luxembourg, Norway, Poland, Spain, and Sweden.
Code Information
All codes