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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic

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 Class 2 Recall
Medtronic
see related information
Date Posted April 08, 2008
Recall Status1 Terminated on July 28, 2008
Recall Number Z-0689-2008
Recall Event ID 46353
Premarket Approval
PMA Number
P990020
Product Classification System, Endovascular Graft, Aortic Aneurysm Treatment - 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, California 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
DESIGN: Packaging 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = MIH and Applicant = MEDTRONIC INC.
PMAs with Product Code = MIH and Applicant = MEDTRONIC ANEURX
PMAs with Product Code = MIH and Applicant = MEDTRONIC AVE, INC.
PMAs with Product Code = MIH and Applicant = MEDTRONIC IRELAND
PMAs with Product Code = MIH and Applicant = MEDTRONIC VASCULAR
PMAs with Product Code = MIH and Applicant = MEDTRONIC VASCULAR GALWAY LIMITED
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