FDA Device recall Z-1049-2017
AFX2 Endovascular AAA System Item No. Item Description F00820-01 BEA28-120/I20-40 F00820-02 BEA28-100/I20-40 F00820-03 BEA28-80/I20-40 F008…
- FDA Device
- Class II
- terminated
- Published 2017-01-25
On 2017-01-25 the FDA classified a Class II recall of AFX2 Endovascular AAA System Item No. Item Description F00820-01 BEA28-120/I20-40 F00820-02 BEA28-100/I20-40 F00820-03 BEA28-80/I20-40 F008… by Endologix, citing endologix updated information on the rates of Type III endoleaks and suggestions for patient surveillance and treatment.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1049-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-01-04 |
| Published | 2017-01-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Endologix |
| Distribution | US |
Product
AFX2 Endovascular AAA System Item No. Item Description F00820-01 BEA28-120/I20-40 F00820-02 BEA28-100/I20-40 F00820-03 BEA28-80/I20-40 F00820-06 BEA28-120/I16-40 F00820-07 BEA28-100/I16-40 F00820-08 BEA28-80/I16-40 F00820-09 BEA28-60/I16-40 F00820-16 BEA28-110/I20-30 F00820-17 BEA28-90/I20-30 F00820-18 BEA28-70/I20-30 F00820-20 BEA28-110/I16-30 F00820-21 BEA28-90/I16-30 F00820-22 BEA28-70/I16-30 F00820-28 BEA25-120/I20-40 F00820-29 BEA25-100/I20-40 F00820-30 BEA25-80/I20-40 F00820-43 BEA25-110/I20-30 F00820-44 BEA25-90/I20-30 F00820-45 BEA25-70/I20-30 F00820-57 BEA22-80/I20-40 F00820-71 BEA22-90/I20-30 F00820-72 BEA22-70/I20-30 The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA
Reason
Endologix updated information on the rates of Type III endoleaks and suggestions for patient surveillance and treatment.
Identifiers
| code_info | 1594192 1594192R013 1590565 1590565014 1590565 1590565008 1520115 1520115008 1354739 1354739019 1354736 1354736002…1594192 1594192R013 1590565 1590565014 1590565 1590565008 1520115 1520115008 1354739 1354739019 1354736 1354736002 1594192 1594192R014 1594192 1594192R010 1594192 1594192R009 1598697 1598697008 1598697 1598697003 1598697 1598697001 1594192 1594192R012 1594192 1594192R006 1590565 1590565009 1590565 1590565004 1590565 1590565002 1517329 1517329008 1517329 1517329006 1517329 1517329005 1516641 1516641008 1516641 1516641006 1472927 1472927006 1354745 1354745011 1354745 1354745009 1354740 1354740008 1354740 1354740002 1354739 1354739021 1354739 1354739017 1354739 1354739014 1354739 1354739010 1354739 1354739001 1578331 1578331008 1473420 1473420027 1613996 1613996014 1588687 1588687010 1588687 1588687007 1519368 1519368006 1517160 1517160008 1473420 1473420008 1586082 1586082001 1473420 1473420025 1613996 1613996015 1613996 1613996013 1613996 1613996012 1613996 1613996010 1613996 1613996007 1613996 1613996005 1613996 1613996003 1596669 159666 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1049-2017%22
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