Reported Apr 2, 2014 · Terminated
Ovation Prime Abdominal Stent Graft System; Manufacturer: TriVascular, Inc. 3910 Brickway Blvd. Santa Rosa, CA 95403…
Trivascular, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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
- ManufacturerTriVascular, 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
- Lot codes and dates
- All codes
- Amount recalled
- 45
Why it was recalled
Communication to European physician users of the Ovation Prime Abdominal Stent Graft system to notify them of changes to Instructions for Use.
This product could cause temporary or reversible health problems — stop using it.
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