Medtronic CardioVascular
AneuRx AAAdvantage stent graft and the Xcelerant Delivery System with Hydro, Product number ILXCH161685, manufactured by Medtronic Cardiovascular, Santa Rosa, CA. The product is designed to treat infrarenal abdominal aortic or aorto-iliac aneurysms during an endovascular approach.
| Date | Sep 16, 2008 (initiated Apr 29, 2008) |
| Status | Terminated |
| Reason | Products may contain elevated endotoxin (pyrogen) levels above the firm's specifications, and the product is labeled as containing no pyrogen. |
| Root cause | Material/Component Contamination |
| Action | 2 consignees were notified by letter delivered in person via sales representative the week of April 28. Both were delivered. For assistance, contact Medtronic CardioVascular at 1-707-566-1548. |
| Quantity | 4 units |
| Distribution | NC and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.