| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2020-RN-01496-1 |
| Product Name/Description |
HeartWare Ventricular Assist Device (HVAD) System
Model number: 1104
Serial numbers: HW30862, HW31092, HW31587, HW34936, HW35315, HW35476, HW35977, HW36032, HW 29653, HW 31133 and HW 31505
ARTG 181875
(Medtronic Australasia Pty Ltd - Heartware Ventricular Assist System - Implantable ventricular circulatory assist system) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
22/12/2020 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic has identified an issue with implanted HeartWare Ventricular Assist Devices (HVADs), where the pump may experience a delay to restart or failure to restart.
An internal pump component from three (3) specific lots puts a subset of the finished pumps at higher risk of delay to restart or failure to restart. The risk exists only when the pump is stopped, for example in a controller exchange when an attempt is made to restart the pump. A delay to restart or failure to restart could occur at any time after a pump stop, even if the pump initially started at the time of implant. If a pump has successfully restarted after a pump stop event, a delay to restart or failure to restart could be experienced in the future. This issue does not impact the performance of a pump while it is running. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Surgeons are advised to notify implanted customers and to follow the additional Patient Management Recommendations provided in the customer letter (supplied by Medtronic to impacted customers).
Medtronic recommends the following actions:
1) Reinforce the current Instructions for Use to patients and staff;
2) Inform patients implanted with one of these identified pumps to contact their VAD coordinator prior to any controller exchange, and to coordinate performing an exchange of controllers in a clinical setting;
3) Controller exchanges should be performed under clinician supervision in a controlled environment with immediate ability to put the patient on hemodynamic support; and
4) If a patient’s controller is beyond two (2) years of service, consider proactively scheduling a controller exchange prior to the internal controller battery reaching end of life and triggering a [Controller Fault] alarm;
Medtronic will notify customers if there are changes to recommendations.
This action has been closed out on 10/06/2021 |
| Contact Information |
02 9857 9000 - Medtronic Customer Service |