| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00256-1 |
| Product Name/Description |
HeartWare Ventricular Assist System
Controller/Controller Kits
Model Numbers (may contain various suffixes): 1400, 1401, 1403, 1407 and 1420
DC Adapter
Model Numbers (may contain various suffixes): 1435 and 1440
AC Adapter
Model Numbers (may contain various suffixes): 1425 and 1430
Battery Pack
Model Numbers (may contain various suffixes): 1650
All Serial Numbers of the above models
ARTG Number: 181875 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
15/05/2018 |
| Responsible Entity |
|
| Reason/Issue |
HeartWare, now a part of Medtronic, has identified the potential for a transient interruption of the electrical connection between an HVAD System power source (Battery, AC Adapter, or DC Adapter) and the HVAD Controller that may result in unintended power switching to the secondary power source and/or unexpected audible tones (“beeping”). This interruption, which occurs while the power source remains physically connected, is due to oxidation of connecting surfaces between a power source connector and the controller’s power source socket, and typically lasts 1-2 seconds.
Unexpected beeping occurs when the interruption automatically resolves and may cause confusion to the patient or caregiver, as the controller may display sufficient battery capacity or AC/DC connectivity at the time of the audible tone. A Critical Battery Alarm may also be momentarily displayed due to this phenomenon. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Medtronic is developing mitigations for current patients and future system enhancements have been identified and pending approval. Medtronic will inform users when these have been made available.
In the interim, Medtronic is providing the following recommendations for power source management of HVAD Systems:
- Reinforce the importance of always ensuring TWO power sources (AC or DC adapter plus a battery, OR two batteries) are connected at all times (except when changing a power source)
- Reinforce best practice guidance for managing power sources when going to sleep and awakening
- Instruct patients to report any persistent, unexpected audible tones to the VAD team for additional instructions
Update June 2018: Medtronic HeartWare Field Representatives will coordinate with surgeons to arrange for service of patient's HVAD power source components. This will include application of a lubricant to all HVAD power sources. It is expected that this will be a one-time field service.
This action has been closed out on 02/11/2020
This action has been closed out on 02/11/2020 |
| Contact Information |
02 9857 9000 - Medtronic Australasia |