Recall Z-0083-2014 ยท MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Medtronic Vascular, Inc.
Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft with the Captivia Delivery System.
| Date | Oct 25, 2013 (initiated Sep 19, 2012) |
| Status | Terminated |
| Reason | Firm received reports of difficulty in flushing the graft cover of the delivery system during device preparation as required by IFU. |
| Root cause | Component design/selection |
| Action | A Medical Device Information letter was sent to all affected customers on September 19, 2012. Additionally, all Medtronic Field Representatives were notified of the issue via a Field Memo |
| Quantity | ~1000 |
| Distribution | International distribution:Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, Germany, Greece, Hungary, Iceland, Ireland, It lay, Latvia, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.