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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 Device Recall Ovation Prime Abdominal Stent Graft Systemsee related information
Date Initiated by FirmFebruary 27, 2014
Date PostedMarch 26, 2014
Recall Status1 Terminated 3 on April 11, 2014
Recall NumberZ-1297-2014
Recall Event ID 67672
PMA NumberP120006S008 
Product Classification System, endovascular graft, aortic aneurysm treatment - Product Code MIH
ProductOvation 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 CA 95403
For Additional Information ContactMeg 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		Device Design
ActionTrivascular 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 Commerce45
DistributionWorldwide Distribution including Austria, Belgium, Czech Republic, France, Germany, Greece, Hungary, Italy, Luxembourg, Norway, Poland, Spain, and Sweden.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA DatabasePMAs with Product Code = MIH
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