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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 Recall
AneuRx AAAdvantage and AneuRx Xcelerant Hydro
see related information
Date Posted September 16, 2008
Recall Status1 Terminated on September 11, 2008
Recall Number Z-1918-2008
Recall Event ID 48097
Premarket Approval
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, California 95403-1774
Consumer Instructions Contact the recalling firm for information
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
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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