Date Initiated by Firm | April 29, 2008 |
Date Posted | September 16, 2008 |
Recall Status1 |
Terminated 3 on September 11, 2008 |
Recall Number | Z-1918-2008 |
Recall Event ID |
48097 |
PMA Number | P990020 |
Product | 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. |
Code Information |
Serial Numbers V00092566, V00092567, V00092568, and V00092569 |
Recalling Firm/ Manufacturer |
Medtronic CardioVascular 3576 Unocal Pl Santa Rosa CA 95403-1774
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For Additional Information Contact | 707-566-1548 |
Manufacturer Reason for Recall | Products may contain elevated endotoxin (pyrogen) levels above the firm's specifications, and the product is labeled as containing no pyrogen. |
FDA Determined Cause 2 | 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 in Commerce | 4 units |
Distribution | NC and VA. |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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