| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00918-1 |
| Product Name/Description |
HeartWare Ventricular Assist System Battery
Product Codes: 1650, 1650-DE
Ranges of Serial Numbers: BAT000001 to BAT199999
ARTG Number: 181875 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
29/09/2015 |
| Responsible Entity |
|
| Reason/Issue |
In May 2014, HeartWare distributed Field Safety Notice FSCA APR2014 following an increase in reported power management complaints related to earlier than expected battery depletion. Information on early battery depletion, identification of potentially faulty batteries, and recommended practices for power management were provided in the Field Safety Notice.
HeartWare is expanding this action to include product code 1650-DE.
There has been an increase in reported power management complaints related to earlier than expected battery depletion. Batteries produced in the ranges BAT000001 to BAT199999 appear more likely to exhibit premature or unrecognised deterioration of battery capacity. |
| Recall Action |
Recall |
| Recall Action Instructions |
HeartWare is advising clinicians to continue to use the batteries in accordance with the IFU and Patient Manual. HeartWare will be replacing all affected batteries in January 2016. |
| Contact Information |
02 8078 6164 - HeartWare Australia |