HeartWare Ventricular Assist Device AC adapters and batteries
Published 11 January 2016
Product
The HVAD system takes over some or all of the pumping function of the heart. The device includes a pump which is attached to the patient's heart and is connected via a driveline to an external controller that regulates the pump's function and monitors the system. The system is implanted either in patients awaiting heart transplants or as an alternative to transplantation. Identifying features description The serial numbers of affected devices are: •HeartWare AC adapters with serial numbers within the range CAC000001 to CAC005796 •HeartWare batteries with serial numbers within the range BAT000001 to BAT199999.
Why it was recalled
Some of HeartWare's AC adapters are vulnerable to power grid surges above 220 volts and, when affected, will automatically switch to a back-up power source (batteries). In addition, some HeartWare batteries supplied before December 2014 have the potential to lose their charge prematurely.
Hazard
In either case there is the potential for additional risk to the patient from not being connected to back-up power sources and this could lead to serious injury or death if the remaining power source is insufficient or fails.
Source: Product Safety Australia. RecallMatch AU provides a screening summary and is independent of the ACCC.