FDA Device recall Z-1038-2017
AFX Endovascular AAA System, Endoleak Type IIIB
- 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 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-1038-2017 |
| 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; 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 | The correction is not lot specific. It applies to AFX procedures conducted after July 2015 |
|---|
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-1038-2017%22
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