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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Medtronic CardioVascular
Lot Codes / Batch Numbers
Serial Numbers V00092566, V00092567, V00092568, and V00092569
Products Sold
Serial Numbers V00092566, V00092567, V00092568, and V00092569
Medtronic CardioVascular is recalling AneuRx AAAdvantage stent graft and the Xcelerant Delivery System with Hydro, Product number ILXCH161 due to Products may contain elevated endotoxin (pyrogen) levels above the firm's specifications, and the product is labeled as containing no pyrogen.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Products may contain elevated endotoxin (pyrogen) levels above the firm's specifications, and the product is labeled as containing no pyrogen.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
NC, VA
Page updated: Jan 10, 2026