HeartWare Ventricular Assist Device AC adapters and batteries
Official notice
11 Jan 2016
Last checked
11 Jan 2016
An official ACCC notice concerns HeartWare Ventricular Assist Device AC adapters and batteries. 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. Published 2016-01-11.
What to do now
If you or someone you care for has an implanted HeartWare device check the serial numbers on your AC adapter(s) and batteries. If the serial numbers are within the ranges listed above you should contact your cardiologist or the hospital where the operation was performed to arrange for replacement. If you are unsure of the serial numbers on your AC adapter(s) and batteries, please contact your cardiologist. If an AC adapter fails, the patient's controller will sound an alarm and automatically switch to an alternative power source. The patient or carer should follow HeartWare’s Instructions for Use (IFU) and patient manual and replace the failed AC adapter with a backup AC adapter (or another power source). If batteries drop their charge prematurely an escalating alarm will sound, notifying the patient/carer of a critical battery condition. In such an event, the patient/carer will need to immediately connect an additional power source to the controller to avoid a pump stop. Patients are advised to always have available two fully charged spare batteries and a spare AC adapter. All AC adapters and batteries with serial numbers in the ranges listed above should be replaced. If you have any questions or concerns regarding this issue, please contact your cardiologist.
Recall number
eccf43b0-150c-43d2-8a13-43331cca7eac
Official notice
2016-01-11
The hazard
The 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.
How to check if you're affected
How to check if you're affected
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