FDA Device recall Z-1039-2017
AFX Endovascular AAA System, Endoleak Type: IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endova…
- FDA Device
- Class II
- terminated
- Published 2017-01-25
On 2017-01-25 the FDA classified a Class II recall of AFX Endovascular AAA System, Endoleak Type: IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endova… by Endologix, citing endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1039-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-12-27 |
| Published | 2017-01-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Endologix |
| Distribution | US |
Product
AFX Endovascular AAA System, Endoleak Type: IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).
Reason
Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).
Identifiers
| code_info | "AFX2 Duraply Lot Codes (July 2015 - Nov. 2016)" Lot Codes 1298056012 1354736007 1354737005 1354738002 13547390…"AFX2 Duraply Lot Codes (July 2015 - Nov. 2016)" Lot Codes 1298056012 1354736007 1354737005 1354738002 1354739002 1354739008 1354739020 1354739027 1354740011 1354745005 1354798002 1354798008 1354798014 1354799004 1354800001 1354800008 1354800014 1354801006 1354801013 1354802004 1354802010 1354804006 1354806001 1354806007 1354806019 1354806026 1354807003 1354807009 1354808003 1354808009 1354809009 1354809015 1354810008 1354810015 1354810022 1354859002 1354859009 1354859016 1354859025 1354860005 1354861001 1354861008 1354861014 1354861021 1354861027 1354862004 1354862011 1354862017 1354862027 1354863007 1354865009 1354865017 1354865025 1354867004 1354867012 1354867020 1354867028 1354921006 1354922002 1354922010 1354922018 1354922024 1354923002 1354923009 1354923015 1354923021 1354924003 1354924012 1354924018 1354924026 1354925005 1354925012 1354925018 1354925024 1354926005 1354926013 1354926020 1354926026 1 |
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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-1039-2017%22
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