Data Foundry

Medical device recalls 2017

AFX Endovascular AAA System — Class II medical device recall Z-1054-2017

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 numberZ-1054-2017
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmEndologix, Irvine, CA, United States
Recall initiated2016-12-27
Classified2017-01-19
Reported by FDA2017-01-25
Terminated2017-04-28
Countries outside the USAT, BE, CH, CZ, DE, ES, FR, GB, GR, IE, IL, IT, LU, LV, NL, PL, PT, SE, TR
Quantity17,139 units
Lot numbers023, 1046835-013, 1053145-002, 1053245-017, 1053247-010, 1053270-012, 1053303-022, 1054635-010, 1055815-014, 1132279-029, 1251688001, 1251688002, 1251688003, 1251688004, 1251688005, 1251688006, 1251688007, 1251688008, 1251688009, 1251688010, 1251688011, 1251688012, 1251688013, 1251688014, 1251688015, 1251688016, 1251688018, 1251688019, 1251688020, 1251688021, 1251688022, 1251688023, 1251688024, 1251688026, 1251688027, 1251688028, 1251688029, 1251688030, 1251689001, 1251689006 and 460 more

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 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-1054-2017. 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.