AneuRx AAAdvantage stent graft and the Xcelerant Delivery System with Hydro, Product number ILXCH161685, manufactured by
FDA device recall Z-1918-2008 · posted 2008-09-16 · Terminated
Recall details
- Recalling firm
- Medtronic CardioVascular
- Reason for recall
- Products may contain elevated endotoxin (pyrogen) levels above the firm's specifications, and the product is labeled as containing no pyrogen.
- 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.
- Root cause
- Material/Component Contamination
- Status
- Terminated
- Quantity affected
- 4 units
- Distribution
- NC and VA.
- Date initiated
- 2008-04-29
- Date posted
- 2008-09-16
- Date terminated
- 2008-09-11
- Location
- Santa Rosa, CA
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