FDA Device recall Z-0288-2013
TriVascular brand Fill Polymer Kit, Endovascular Graft, Aneurysm Treatment System, European Model Number: TVFP14-B, (in European distributo…
- FDA Device
- Class II
- terminated
- Published 2012-11-21
On 2012-11-21 the FDA classified a Class II recall of TriVascular brand Fill Polymer Kit, Endovascular Graft, Aneurysm Treatment System, European Model Number: TVFP14-B, (in European distributo… by Trivascular, citing 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 i….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0288-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-10-19 |
| Published | 2012-11-21 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Trivascular |
| Distribution | US |
Product
TriVascular brand Fill Polymer Kit, Endovascular Graft, Aneurysm Treatment System, European Model Number: TVFP14-B, (in European distributor inventory only); PRODUCT Usage: The 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
Reason
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
Identifiers
| code_info | The following lot numbers are in distributor inventory in Europe: FF121211-04, FF010912-01, FF013112-01, FF020912-0…The following lot numbers are in distributor inventory in Europe: FF121211-04, FF010912-01, FF013112-01, FF020912-01, FF022212-03, FF022912-01, FF040412-01, FF051012-01 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0288-2013%22
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