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Terminated

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.

FDA Recall Z-1918-2008 · Posted 2008-09-16

Recalling FirmMedtronic CardioVascular
Recall StatusTerminated
Date Initiated2008-04-29
Date Terminated2008-09-11
Product Quantity4 units

Reason for Recall

Products may contain elevated endotoxin (pyrogen) levels above the firm's specifications, and the product is labeled as containing no pyrogen.

Firm 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.

Root Cause

Material/Component Contamination

Distribution Pattern

NC and VA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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