FDA Medical Device Recalls (openFDA)
Medtronic CardioVascular: 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
- Recall number
- Z-0689-2008
- Recalling firm
- Medtronic CardioVascular
- 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
- Status
- Terminated
- Initiated
- 2007-12-10
- Posted
- 2008-04-08
- Terminated
- 2008-07-28
- Reason
- Sterility compromised: Device sterility may be compromised as evidenced by a loss of outer package integrity.
- 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
- 7,000
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- All codes
- 510(k) numbers
- not on file
- PMA numbers
- ["P990020"]
- Product code
- MIH
- Firm FEI
- 3001452571
- Firm city
- Santa Rosa
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28