# P040002: Endologix Powerlink System

- Pathway: PMA
- Applicant: Endologix, LLC
- Decided: Oct 29, 2004 after 295 days
- Product code: MIH (System, Endovascular Graft, Aortic Aneurysm Treatment)
- Device class: 3
- Recalls of this device: 16 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 1 cites it directly.
1 of 9 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Most influential descendants
- K110090: Afx Introducer System (2011), 7 descendants of its own
- K111747: Endologix Afx Introducer System (2011), 6 descendants of its own
- K120212: Afx Introducer System (2012), 5 descendants of its own
- K141275: Endophys Pressure Sensing Sheath Kit (2015), 4 descendants of its own
- K160272: Endophys Pressure Sensing Sheath Kit (2016), 3 descendants of its own

## Recalls of this device
- Jan 4, 2017 · Class II · Z-1049-2017: Endologix updated information on the rates of Type III endoleaks and suggestions for patient surveillance and treatment.
- Jan 4, 2017 · Class II · Z-1048-2017: Endologix updated information on the rates of Type III endoleaks and suggestions for patient surveillance and treatment.
- Dec 27, 2016 · Class II · Z-1038-2017: Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).
- Dec 27, 2016 · Class II · Z-1047-2017: Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).
- Dec 27, 2016 · Class II · Z-1037-2017: Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).
- Dec 27, 2016 · Class II · Z-1035-2017: Endologix initiated a correction by updating reports for the cumulative clinical data and information on the Powerlink System and the AFX Endovascular AAA System (AFX System).
- Dec 27, 2016 · Class II · Z-1039-2017: Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).
- Dec 27, 2016 · Class II · Z-1054-2017: Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).
- Dec 14, 2005 · Not classified · Z-0590-06: The tip may separate from the catheter sheath inner core during insertion of the graft. The delivery catheter is being recalled. The implanted devices are not affected.
- Dec 14, 2005 · Not classified · Z-0591-06: The tip may separate from the catheter sheath inner core during insertion of the graft. The delivery catheter is being recalled. The implanted devices are not affected.
- Dec 14, 2005 · Not classified · Z-0592-06: The tip may separate from the catheter sheath inner core during insertion of the graft. The delivery catheter is being recalled. The implanted devices are not affected.
- Dec 14, 2005 · Not classified · Z-0594-06: The tip may separate from the catheter sheath inner core during insertion of the graft. The delivery catheter is being recalled. The implanted devices are not affected.
- Dec 14, 2005 · Not classified · Z-0595-06: The tip may separate from the catheter sheath inner core during insertion of the graft. The delivery catheter is being recalled. The implanted devices are not affected.
- Dec 14, 2005 · Not classified · Z-0589-06: The tip may separate from the catheter sheath inner core during insertion of the graft. The delivery catheter is being recalled. The implanted devices are not affected.
- Dec 14, 2005 · Not classified · Z-0596-06: The tip may separate from the catheter sheath inner core during insertion of the graft. The delivery catheter is being recalled. The implanted devices are not affected.
- Dec 14, 2005 · Not classified · Z-0593-06: The tip may separate from the catheter sheath inner core during insertion of the graft. The delivery catheter is being recalled. The implanted devices are not affected.

Source page: https://510kreport.com/device/P040002
Methodology: https://510kreport.com/methodology