Reported Nov 21, 2012 · Terminated
TriVascular brand Fill Polymer Kit, Endovascular Graft, Aneurysm Treatment System, European Model Number: TVFP14-B, (in…
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?
- TriVascular brand Fill Polymer Kit, Endovascular Graft, Aneurysm Treatment System
- European Model NumberTVFP14-B, (in European distributor inventory only)
- PRODUCT UsageThe TriVascular Ovation Abdominal Stent Graft System is indicated in subjects diagnosed with an aneurysm in the abdominal aorta having vascular morphology suitable for endovascular repair
- including(1) Adequate iliac/femoral access compatible with vascular access techniques, devices, and/or accessories, (2)
- Non-aneurysmal proximal aortic neck- with a length of at least 7 mm proximal to the aneurysm, - with an inner wall diameter of no less than 16 mm and no greater than 30 mm, and - with an aortic angle of d 60 degrees if proximal neck is e 10 mm and d 45 degrees if proximal neck is < 10 mm, (3) Non-aneurysmal
- distal iliac landing zone- with a length of at least 10 mm, - with an inner wall diameter of no less than 8 mm and no greater than 20 mm
- Lot codes and dates
- The following lot numbers
- are in distributor inventory in Europe
FF121211-04FF010912-01FF013112-01FF020912-01FF022212-03FF022912-01FF040412-01FF051012-01
- Amount recalled
- 41 units
Where it was sold
- Nationwide
Why it was recalled
Selected lots of the Fill Polymer Kit (European Model Number: TVFP14- B) in European distributor inventory only that potentially contain leaking stopcocks due to possible cracks in the stopcock component. TriVascular indicated that these Fill Polymer Kits are for use with the Ovation or Ovation Prime Abdominal Stent Graft Systems that may display leaks upon initiation of mix but prior to use in
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Trivascular, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.