Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:29211
Brand Name:Heartware - Ventricular Assist System (HVAD)
Model:PUMP 1104 HVAD 2.0 IMPLANT KIT EN - model number 1104
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 has received complaints regarding inconsistencies in the product literature resulting in no patient harm. Potential harms from these inconsistencies can result in confusion and annoyance.
Recall action type:Correction
Recall action:Instructions for use to be updated
Level of recall:Healthcare Professional
Date Commenced:4/4/2022
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