AFX Endovascular AAA System — Class II medical device recall Z-1047-2017
Terminated recall by Endologix, reported 2017-01-25. Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA Sys
| Recall number | Z-1047-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Endologix, Irvine, CA, United States |
| Recall initiated | 2016-12-27 |
| Classified | 2017-01-18 |
| Reported by FDA | 2017-01-25 |
| Terminated | 2017-04-28 |
| Countries outside the US | AT, BE, CH, CZ, DE, ES, FR, GB, GR, IE, IL, IT, LU, LV, NL, PL, PT, SE, TR |
Product
AFX Endovascular AAA System, Endoleak Type IIIA Product Usage: The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).
Reason for recall
Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1047-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.