PMA · Approved
Recalled · Class II · 2017Endologix Powerlink System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endologix, LLC · MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Approved on Oct 29, 2004 through premarket approval, which rests on the device’s own clinical evidence after a 295-day review. 1 of the 9 devices in its family, counting itself, has a Class I recall. 8 later devices descend from it. It has been recalled 16 times.
- Decided
- Oct 29, 2004
- Review
- 295 days
- Class
- Class III
- Product code
- MIH
- Recalls
- 16
8 later devices descend from it, 1 citing it directly. 1 of the 9 devices in this family, counting this one, has a Class I recall.
- This deviceP040002 Endologix Powerlink SystemEndologix, LLC · 2004
- Descendant · cites it directly · 7 of its ownK110090 Afx Introducer SystemEndologix, Inc. · 2011
- Descendant · 2 generations on · 6 of its ownK111747 Endologix Afx Introducer SystemEndologix, Inc. · 2011
- Descendant · 3 generations on · 5 of its ownK120212 Afx Introducer SystemEndologix, Inc. · 2012 · Recalled (Class I)
- Descendant · 4 generations on · 4 of its ownK141275 Endophys Pressure Sensing Sheath KitEndophys, Inc. · 2015
- Descendant · 5 generations on · 3 of its ownK160272 Endophys Pressure Sensing Sheath KitEndophys, Inc. · 2016
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K120212 Afx Introducer System3 generations on · 2012
Most influential descendants
Showing 5 of 8 · See all- K110090Afx Introducer SystemEndologix, Inc. · 2011 · cites it directly7descendants
- K111747Endologix Afx Introducer SystemEndologix, Inc. · 2011 · 2 generations on6descendants
- K120212Afx Introducer SystemEndologix, Inc. · 2012 · 3 generations on5descendants
- K141275Endophys Pressure Sensing Sheath KitEndophys, Inc. · 2015 · 4 generations on4descendants
- K160272Endophys Pressure Sensing Sheath KitEndophys, Inc. · 2016 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P040002 | Endologix Powerlink System | Endologix, LLC | 2004 | — |
| +1 | K110090 | Afx Introducer System | Endologix, Inc. | 2011 | — |
| +2 | K111747 | Endologix Afx Introducer System | Endologix, Inc. | 2011 | — |
| +3 | K120212 | Afx Introducer System | Endologix, Inc. | 2012 | Class I |
| +4 | K141275 | Endophys Pressure Sensing Sheath Kit | Endophys, Inc. | 2015 | — |
| +5 | K160272 | Endophys Pressure Sensing Sheath Kit | Endophys, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 1 | 1 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110090 | Afx Introducer System | 2011 | 7 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 4, 2017 | Class II | Z-1049-2017 | Device Design | 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 | Device Design | 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 | Other | 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 | Nonconforming Material/Component | 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 | Device Design | 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 | Other | 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 | Device Design | 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 | Under Investigation by firm | 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 | Other | 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 | Other | 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 | Other | 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 | Other | 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 | Other | 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 | Other | 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 | Other | 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 | Other | 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. |
The 5 latest of 16 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K120212Afx Introducer SystemEndologix, Inc. · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K110090 (Endologix, Inc., 2011) has gone furthest, with 7 descendants of its own.
How does its category compare?
All MIH devicesMIH System, Endovascular Graft, Aortic Aneurysm Treatment: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MIH
50in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MIH
Too few MIH 510(k)s in any year since 2007 to give a median.
Recalls per year · MIH
1in 2025
Class I (7 since 2007) Class II/III not classified
Adverse event reports per year · MIH
3,302in 2025
MAUDE reports naming product code MIH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 33 | — | 1 | 1,323 |
| 2008 | 45 | — | 0 | 1,745 |
| 2009 | 49 | — | 0 | 2,600 |
| 2010 | 46 | — | 0 | 2,493 |
| 2011 | 64 | — | 29 | 3,241 |
| 2012 | 57 | — | 3 | 3,787 |
| 2013 | 48 | — | 0 | 3,883 |
| 2014 | 80 | — | 1 (1) | 4,249 |
| 2015 | 53 | — | 1 | 4,471 |
| 2016 | 47 | — | 6 | 4,296 |
| 2017 | 41 | — | 3 | 4,105 |
| 2018 | 39 | — | 4 (4) | 4,178 |
| 2019 | 34 | — | 0 | 3,592 |
| 2020 | 44 | — | 4 | 3,057 |
| 2021 | 50 | — | 4 | 3,686 |
| 2022 | 49 | — | 2 | 3,455 |
| 2023 | 50 | — | 0 | 3,562 |
| 2024 | 62 | — | 0 | 3,320 |
| 2025 | 50 | — | 1 (1) | 3,302 |
| 2026 | 35 | — | 2 (1) | — |
https://510kreport.com/device/P040002 · printed Nov 6, 2026
Cite this page
510(k) Report. “P040002: Endologix Powerlink System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P040002
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026