Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:23496
Brand Name:AFX & AFX2 EndoVascular AAA system
Model:AFX Endovascular AAA System - All models
Affected:
Software version:
Recalling Organisation:Endologix New Zealand Co.
Level 27
88 Shortland Street
Auckland 1010
Contact Information:
Manufacturer:Endologix International BV
Issue:The manufacturer has conducted investigations into reports of Type III endoleaks which may cause increased pressure within the aneurysm sac that could increase the risk of aneurysm rupture and patient death.
Recall action type:Correction
Recall action:Instructions for use to be updated
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:24/8/2018
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