| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00902-1 |
| Product Name/Description |
HeartWare Ventricular Assist System batteries
Product code: 1650
Serial number range for the affected batteries: BAT000001 to BAT039999; BAT090000 to BAT099999
ARTG number:181875 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
14/08/2014 |
| Responsible Entity |
|
| Reason/Issue |
In May 2014, HeartWare distributed Recall for Product Correction letter (TGA Ref: RC-2014-RN-00510-1/ HeartWare Ref: FSCA APR2014.1) 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 Recall for Product Correction letter.
HeartWare is expanding the action to include the recall of batteries produced within the serial number ranges: BAT000001 to BAT039999 and BAT090000 to BAT099999. Batteries produced in these ranges are more likely to exhibit premature or unrecognized deterioration of battery capacity, which poses a risk to the patient since it may result in a pump stop. |
| Recall Action |
Recall |
| Recall Action Instructions |
HeartWare is requesting their clinicians to review their hospital’s current inventory and remove and quarantine any affected batteries. At each patient’s next regularly scheduled visit, inspect their batteries and replace affected batteries with batteries having serial numbers BAT040000 to BAT089999 or BAT100000 and above. If a patient does not have a regular visit scheduled within the next 90 days, contact that patient by telephone to check the serial numbers of the patient’s batteries. This action has been closed-out on 13/10/2016. |
| Contact Information |
02 8078 6164 - HeartWare Pty Ltd |