| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00358-1 |
| Product Name/Description |
HeartWare HVAD Controllers and Heartware 1435 DC Adapters
HeartWare HVAD Controllers
Serial Numbers below CON3000000
Heartware 1435 DC Adapters
All Serial Numbers
ARTG Number: 291465 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/08/2017 |
| Responsible Entity |
|
| Reason/Issue |
HeartWare has developed an updated HeartWare HVAD System Controller following two previously communicated Urgent Field Safety Notices that occurred in April 2015 and April 2016.
With the introduction of the updated HVAD Controller, also referred to as Controller 2.0, HeartWare is initiating removal procedures for previous generation HeartWare HVAD Controllers with serial numbers lower than CON300000, and all HeartWare DC Adapters, product code 1435 (all serial numbers), which are incompatible with the new HVAD Controller. The removal of these HVAD Controllers and DC Adapters will occur concurrently with the introduction of the new HVAD Controller.
The new HVAD Controller includes enhancements to address the potential safety issues identified in April 2015 and 2016. |
| Recall Action |
Recall |
| Recall Action Instructions |
1. Review the HeartWare supplied notice/forms, & forward the notice to individuals who need to be aware of its contents.
2. Complete, sign & return the supplied Acknowledgement Form to HeartWare.
3. Complete training that will be scheduled & conducted by HeartWare, which is required before new HVAD Controllers will be distributed. Patients must be educated on using the new HVAD Controller by hospital staff who have received training from HeartWare. Do not exchange current HVAD Controllers and DC Adapters until after this training.
4. Quarantine & replace affected HVAD Controllers, DC Adapters, IFUs, Emergency Responder Guides & Patient Manuals in hospital inventory after training is complete.
5. Notify and schedule an appointment for each patient ASAP to exchange their controllers.
6. Return all quarantined HVAD Controllers & DC Adapters to HeartWare.
7. Once affected product has been identified and returned, complete & return the supplied Completion Form to HeartWare.
This action has been closed out on the 11/10/2018. |
| Contact Information |
02 9857 9189 - Medtronic |