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.
This recall has been terminated (originally issued September 16, 2008).
- Company
- Medtronic Cardiovascular
- Recall Initiated
- April 29, 2008
- Posted
- September 16, 2008
- Terminated
- September 11, 2008
- Recall Number
- Z-1918-2008
- Quantity
- 4 units
- Firm Location
- Santa Rosa, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Products may contain elevated endotoxin (pyrogen) levels above the firm's specifications, and the product is labeled as containing no pyrogen.
Distribution
NC and VA.
Lot / Code Info
Serial Numbers V00092566, V00092567, V00092568, and V00092569
Root Cause
Material/Component Contamination
Action Taken
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.
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