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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic

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  Class 2 Device Recall Medtronic see related information
Date Initiated by Firm December 10, 2007
Date Posted April 08, 2008
Recall Status1 Terminated 3 on July 28, 2008
Recall Number Z-0689-2008
Recall Event ID 46353
PMA Number P990020 
Product Classification Endovascular Stent - Product Code MIH
Product 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
Code Information All codes
Recalling Firm/
Manufacturer		 Medtronic CardioVascular
3576 Unocal Pl
Santa Rosa CA 95403-1774
For Additional Information Contact Jonathan Morris
707-566-1110
Manufacturer Reason
for Recall		 Sterility compromised: Device sterility may be compromised as evidenced by a loss of outer package integrity.
FDA Determined
Cause 2		 Package design/selection
Action 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.
Quantity in Commerce 7,000
Distribution Nationwide Distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = MIH and Original Applicant = Medtronic Vascular
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