Medtronic brand AneuRx AAAdvantage Endovascular Stent Graft with the Xcelerant Delivery System; Model Numbers Affected: All AAAdvantage models including: AEXC202040, IEXC121255, ILXC1212115, ILXC151585, AEXC222240, IEXC131355, ILXC1212135, ILXC1616115, AEXC242440, IEXC141455, ILXC121285, ILXC1616135, AEXC262640, IEXC151555, ILXC1313115, ILXC161685, AEXC282840, IEXC161655, ILXC1313135, ILXC1620115, BFXC2012135, IEXC162085, ILXC131385, ILXC1620135, BFXC2012165, IEXC181855, ILXC1414115, ILXC1818115, BFXC2213135, IEXC182285, ILXC1414135, ILXC1818135, BFXC2213165, IEXC182485, ILXC141485, ILXC181885, BFXC2414135, IEXC202055, ILXC1515115, ILXC1822115, BFXC2414165, ILXC1515135, ILXC1822135, BFXC2615135, ILXC1824115, BFXC2615165, ILXC1824135, BFXC2816135, ILXC2020115, BFXC2816165, ILXC2020135, ILXC202085; Product is manufactured and distributed by Medtronic, Inc., Santa Rosa, CA 95403
This recall has been terminated (originally issued April 8, 2008).
- Company
- Medtronic Cardiovascular
- Recall Initiated
- December 10, 2007
- Posted
- April 8, 2008
- Terminated
- July 28, 2008
- Recall Number
- Z-0689-2008
- Quantity
- 7,000
- Firm Location
- Santa Rosa, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Sterility compromised: Device sterility may be compromised as evidenced by a loss of outer package integrity.
Distribution
Nationwide Distribution.
Lot / Code Info
All codes
Root Cause
Package design/selection
Action Taken
Medtronic sent Urgent Communication - Medical Device Correction Advisory Notice letters to all its direct consignees on 12/7/07, via Federal Express, informing them of the affected product and providing instructions on avoiding contamination of the sterile surgical field with these devices.
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