Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:14214
Brand Name:HeartWare Ventricular Assist System
Model:Product codes: 1100, 1101, 1102, 1104, 1205
Affected:Serial Numbers: HW001 to HW3827 and HW10000 to HW10675
Software version:
Recalling Organisation:Health New Zealand - Te Whatu Ora
9 Ruskin Street
Parnell
Auckland 1052
Contact Information:
Manufacturer:HeartWare International Inc
Issue:There is potential for the rear portion of the HVAD Pump's driveline connector housing partially or fully separating from the front portion of the driveline connector. If unattended, the electrical connection to the controller could be affected and loss of mechanical circulatory support may occur.
Recall action type:Correction
Recall action:Product to be modified
Level of recall:Public Recall
Date Commenced:14/2/2013
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