Z-0689-2008

Medtronic brand AneuRx AAAdvantage Endovascular Stent Graft with the Xcelerant Delivery System; Model Numbers...

Name: Z-0689-2008 Medtronic brand AneuRx AAAdvantage Endovascular Stent Graft with the Xcelerant Delivery System; Model Numbers...
Creator: Medtronic CardioVascular
Published: 2007-12-10
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2007-12-10 / Terminated / root cause: packaging

FDA source

Medtronic CardioVascular began a recall of Medtronic brand AneuRx AAAdvantage Endovascular Stent Graft with the Xcelerant Delivery System; Model Numbers Affected: All AAAdvantage models including... on 2007-12-10. The reason FDA records is "Sterility compromised: Device sterility may be compromised as evidenced by a loss of outer package integrity". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0689-2008
Status: Terminated
Initiated: 2007-12-10
Posted: 2008-04-08
Terminated: 2008-07-28
Recalling firm: Medtronic, Inc.
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
Product code: MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Reason for recall: Sterility compromised: Device sterility may be compromised as evidenced by a loss of outer package integrity.
Root cause tag: packaging
FDA root cause: 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.
Product codes and lots: All codes

Product code MIH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)