Reported Nov 12, 2014 · Terminated

Ovation Prime Abdominal Stent Graft System - 29mm Aortic Body stent grafts. The TriVascular Ovation Prime Abdominal…

Trivascular, Inc.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Trivascular, Inc · 3910 Brickway Blvd · Santa Rosa, CA · 95403

Is this the product you have?

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).

Lot codes and dates: 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 NumberTV-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"
Amount recalled: 0 Devices

Why it was recalled

Stop using this product now

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.

Using this product could cause serious injury, illness or death — stop using it now.

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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By hazard

Medical device recalls

Other recalls from Trivascular, Inc.

Ovation Prime Abdominal Stent Graft System Apr 2, 2014
TriVascular brand Fill Polymer Kit, Endovascular Graft, Aneurysm Treatment System… Nov 21, 2012

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