Recall Z-0689-2008 ยท MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Medtronic CardioVascular
Medtronic brand AneuRx AAAdvantage Endovascular Stent Graft with the Xcelerant Delivery System; Model Numbers Affected: All AAAdvantage models including: AEXC202040, IEXC121255, ILXC1212115, ILXC151585, AEXC222240, IEXC131355, ILXC1212135, ILXC1616115, AEXC242440, IEXC141455, ILXC121285, ILXC1616135, AEXC262640, IEXC151555, ILXC1313115, ILXC161685, AEXC282840, IEXC161655, ILXC
| Date | Apr 8, 2008 (initiated Dec 10, 2007) |
| Status | Terminated |
| Reason | Sterility compromised: Device sterility may be compromised as evidenced by a loss of outer package integrity. |
| Root cause | Package design/selection |
| Action | Medtronic sent Urgent Communication - Medical Device Correction Advisory Notice letters to all its direct consignees on 12/7/07, via Federal Express, informing them of the affected product and providing instructions on avoiding contamination of the sterile surgical field with these devices. |
| Quantity | 7,000 |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.