FDA Device recall Z-1035-2017
AFX Endovascular AAA System, Endoleak Type IIIA
- 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 IIIA by Endologix, citing 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).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1035-2017 |
| 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 IIIA
Reason
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).
Identifiers
| code_info | The correction is not lot specific. It applies to AFX procedures conducted after June 2013 |
|---|
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-1035-2017%22
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