Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2015-RN-01261-1
Product Name/Description HeartWare HVAD Controller AC Adapter and HeartWare HVAD Battery

Controller AC Adapter
Product Code: 1430XX
Serial Numbers: CAC000001 to CAC005796

HVAD Battery
Product Code: 1650XX and A00035
Serial Numbers: BAT000001 to BAT199999

ARTG Number: 181875
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 7/01/2016
Responsible Entity Heartware Pty Ltd
Reason/Issue HeartWare AC Adapters with serial numbers CAC000001 to CAC005796 are vulnerable to power grid surges above 220 volts.
If an AC Adapter fails, the patient’s Controller will alarm and automatically switch to the other power source. If patients follow HeartWare’s Patient Manual, there are no elevated risks to health. However, if a patient is not connected to two power sources, or if the second power source is insufficient to power the system during the time that it takes to replace a failed AC Adapter, the system could lose power, which may lead to serious injury or death.

In addition, there have been complaints related to earlier than expected battery depletion for batteries with serial numbers BAT000001 to BAT199999. Premature or unrecognised battery depletion may pose a risk to the patient, if the patient is not connected to two power sources, or if the second power source is insufficient to power the system during the time that it takes to replace a depleted battery.
Recall Action Hazard Alert
Recall Action Instructions The sponsor is advising healthcare professionals to identify and quarantine the affected units in hospital inventory and arrange for current patients to bring their AC Adapters and Batteries to a clinic as soon as possible (at least within the next three months), with urgency dependent upon individual patient circumstances. During their scheduled appointment, a qualified representative will assist with the quarantine and replacement of the affected product. For further information, please see http://www.tga.gov.au/alert/heartware-ventricular-assist-device-ac-adapters-and-batteries .

This action has been closed out on the 13/12/2018.
Contact Information 02 8935 9400 - HeartWare representative