Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:29614
Brand Name:Heartware - HeartWare Battery
Model:1650DE
Affected:
Software version:
Recalling Organisation:Medtronic New Zealand Limited
Unit 16 Mezzanine Level
5 Gloucester Park Road
Onehunga
AUCKLAND
Contact Information:0800 377 807
Manufacturer:HeartWare Inc
Issue:The manufacturer is informing customers that the change to the battery configuration mode to mitigate the battery electrical fault issue has been implemented, and the manufacturer will begin exchanging all batteries for the new batteries with the mode change. As described in the July 2022 letter, battery electrical faults (issue #2) were caused by an interaction between the software configuration that governs the HVAD battery and an internal component.
Recall action type:Recall
Recall action:Manufacturer to issue advice regarding use
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:2/6/2023
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