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U.S. Department of Health and Human Services

Class 2 Device Recall Ovation Prime Abdominal Stent Graft System

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 Class 2 Recall
Ovation Prime Abdominal Stent Graft System
see related information
Date Posted March 26, 2014
Recall Status1 Terminated on April 11, 2014
Recall Number Z-1297-2014
Recall Event ID 67672
Premarket Approval
PMA Number
P120006/S008
Product Classification System, Endovascular Graft, Aortic Aneurysm Treatment - Product Code MIH
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.
Code Information All codes
Recalling Firm/
Manufacturer
Trivascular, Inc
3910 Brickway Blvd
Santa Rosa, California 95403
For Additional Information Contact Meg Carr
707-543-8805
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = MIH and Applicant = TRIVASCULAR INC
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