FDA Device recall Z-1054-2017
AFX Endovascular AAA System, Endoleak Type IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovas…
- 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, Endovas… 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-1054-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-12-27 |
| Published | 2017-01-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Endologix |
| Distribution | n/a |
Product
AFX Endovascular AAA System, Endoleak Type IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment
Reason
Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).
Identifiers
| code_info | "AFX Duraply Lot Codes (July 2015 - Nov. 2016)" Lot Codes 1046835-013 1054635-010 1251688004 1251688010 1251688…"AFX Duraply Lot Codes (July 2015 - Nov. 2016)" Lot Codes 1046835-013 1054635-010 1251688004 1251688010 1251688016 1251688023 1251688030 1251689010 1251689021 1251689027 1251690005 1251690018 1251690024 1251692020 1251692027 1251740006 1251740013 1251740020 1251740026 1251740032 1251740038 1251740044 1251740050 1251740056 1251741003 1251741010 1251741016 1251741023 1251741029 1251742006 1251742014 1251742022 1251742032 1251742038 1251742045 1251742052 1251742058 1251743005 1251743012 1251743018 1251743027 1251744005 1251744012 1251745004 1251745010 1251745017 1251745026 1251747003 1251747026 1251748005 1251748016 1251748024 1251750003 1251750009 1251750027 1251751004 1251751012 1251751020 1251751029 1251751035 1251751043 1251751049 1251751057 1251752006 1251752012 1251752019 1251752025 1251753003 1251753010 1251753020 1251754003 1251754009 1251754015 1251754026 1251755004 1251755010 1251755016 1251755025 |
|---|
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-1054-2017%22
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