| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00510-1 |
| Product Name/Description |
HeartWare Ventricular Assist System batteries
Product Code: 1650
All HeartWare Battery Serial Numbers
ARTG Number: 181875 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
5/05/2014 |
| Responsible Entity |
|
| Reason/Issue |
HeartWare has seen an increase in reported HeartWare System power management complaints related to both premature battery failure and routine battery handling. Premature or unrecognised deterioration of battery capacity or lapses in recommended power management pose a risk to the patient and, although rare, may result in serious injury or death. This action is intended to provide patients and healthcare providers with information to recognise batteries with less than two hours of run time, re-emphasise instruction on actions to take when battery alarms occur and reinforce proper power management. Early recognition of premature battery depletion, patient training and close attention to recommended power management practices are crucial to reduce patient risk. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
HeartWare is providing information to assist patients and health professionals to monitor battery performance and recognise abnormal behaviour. Health professionals are advised to reinforce the recommended practices for early detection of abnormal battery behaviour and effective power management with their patients. The customer letters identifies the steps to verify that all patients with the HeartWare Batteries are managing their power sources in a safe manner and that batteries are handled in accordance with the Instructions for Use. HeartWare is also advising that complaints will continue to be closely monitored to ensure that the HeartWare System functions as intended and to assess the effectiveness of this field correction. HeartWare will continue to investigate prematurely depleting batteries and will take additional actions as appropriate. |
| Contact Information |
02 8078 6164 - HeartWare Inc |