Recall Z-0288-2013 ยท MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Trivascular, Inc
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/femor
| Date | Nov 13, 2012 (initiated Oct 19, 2012) |
| Status | Terminated |
| 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 |
| Root cause | Nonconforming Material/Component |
| Action | Trivascular sent an Urgent Field Safety Notice letter dated October 19, 2012 to all affect consignees. A verbal (telephone) communication was also initiated. The forms communication identified the affected product, problem and actions to be taken. Consignees were instructed to immediately quarantine and return affected products. A return response form was included for consignees to complete and returned via the e-mail address or fax number provided. Consignees were instructed to further notify its (sub-level) consignees, and have them return affected product directly to the recalling fir |
| Quantity | 41 units |
| Distribution | Worldwide Distribution - US Nationwide and the countries of Belgium, Cyprus, Italy, Spain, Switzerland and Turkey. TriVascular stated that no purchased devices are in hospital inventory in Europe or the U.S. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.