Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:20520
Brand Name:100825 HVAD Pump
Model:1104
Affected:
Software version:
Recalling Organisation:Health New Zealand - Te Whatu Ora
9 Ruskin Street
Parnell
Auckland 1052
Contact Information:
Manufacturer:HeartWare International Inc
Issue:Recall of specified implant kits (pumps) whichmay be more susceptible to electrical faults if the driveline becomes contaminated.
Contaimination of the driveline-to-controller connector can occur during the implant procedure or post operatively from fluid ingress into the driveline.
Manufacturer has implemented manufacturing process improvements designed to prevent drivelne connector contamination in new implant kits.
Recall action type:Recall
Recall action:
Level of recall:
Date Commenced:18/8/2016
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