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U.S. Department of Health and Human Services

Class 1 Device Recall Ovation Prime Abdominal Stent Graft System

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  Class 1 Device Recall Ovation Prime Abdominal Stent Graft System see related information
Date Initiated by Firm September 20, 2014
Date Posted November 03, 2014
Recall Status1 Terminated 3 on December 04, 2014
Recall Number Z-0125-2015
Recall Event ID 69326
PMA Number P120006 
Product Classification System, endovascular graft, aortic aneurysm treatment - Product Code MIH
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).

Code Information 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"
Recalling Firm/
Manufacturer		 Trivascular, Inc
3910 Brickway Blvd
Santa Rosa CA 95403
For Additional Information Contact Tim Doolin
707-543-8732
Manufacturer 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 Determined
Cause 2		 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.
Total Product Life Cycle TPLC 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 Database PMAs with Product Code = MIH and Original Applicant = Endologix, LLC
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