FDA Medical Device Recalls (openFDA)
Medtronic CardioVascular: AneuRx AAAdvantage stent graft and the Xcelerant Delivery System with Hydro, Product number ILXCH161685, manufactured by Medtronic Cardiovascular, Santa Rosa, CA. The product is designed to treat infrarenal abdominal aortic or aorto-iliac aneurysms during an endovascular approach.
- Recall number
- Z-1918-2008
- Recalling firm
- Medtronic CardioVascular
- Product
- AneuRx AAAdvantage stent graft and the Xcelerant Delivery System with Hydro, Product number ILXCH161685, manufactured by Medtronic Cardiovascular, Santa Rosa, CA. The product is designed to treat infrarenal abdominal aortic or aorto-iliac aneurysms during an endovascular approach.
- Status
- Terminated
- Initiated
- 2008-04-29
- Posted
- 2008-09-16
- Terminated
- 2008-09-11
- Reason
- Products may contain elevated endotoxin (pyrogen) levels above the firm's specifications, and the product is labeled as containing no pyrogen.
- Root cause
- Material/Component Contamination
- Action
- 2 consignees were notified by letter delivered in person via sales representative the week of April 28. Both were delivered. For assistance, contact Medtronic CardioVascular at 1-707-566-1548.
- Quantity
- 4 units
- Distribution
- NC and VA.
- Lot, serial or model codes
- Serial Numbers V00092566, V00092567, V00092568, and V00092569
- 510(k) numbers
- not on file
- PMA numbers
- ["P990020"]
- Product code
- not on file
- 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