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U.S. Department of Health and Human Services

Class 2 Device Recall AneuRx AAAdvantage and AneuRx Xcelerant Hydro

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  Class 2 Device Recall AneuRx AAAdvantage and AneuRx Xcelerant Hydro see related information
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
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.
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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