| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2020-RN-00102-1 |
| Product Name/Description |
Medtronic HeartWare HVAD System Battery Charger AC Adapter and Controller
Model Numbers: 1610AU, 1640AU
All Serial Numbers
ARTG: 277518, 277480 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
31/01/2020 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic HeartWare advises of the potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVAD Controller power port. When this occurs, communication circuits between the battery and the Controller may be damaged. If circuit damage occurs, it will be necessary to exchange the Controller to restore communication between the batteries and Controller.
Power to the Controller and to the HeartWare HVAD Pump will continue to be maintained if a Battery Charger AC Adapter is mistakenly inserted into a Controller power port and a secondary power source also is connected to the Controller.
Medtronic will be providing an addition to the clinician HVAD Instructions For Use (IFU) and Patient Manual.
Through January 13, 2020, there have been 36 complaints reported to Medtronic potentially related to this issue. From this population, there has been one reported death resulting from complications associated with a related Controller exchange. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Medtronic is advising clinicians to instruct patients to carefully follow the guidance provided in the updated patient manual related to connecting a power source.
Patients are advised to pay attention when connecting and disconnecting power supply cables to ensure the correct cable is being connected to their Controller.
Medtronic will provide a copy of the updated IFU and Patient Manual to all customers once it is approved for release. |
| Contact Information |
02 9857 9000 - Medtronic Customer Service |