| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00761-1 |
| Product Name/Description |
HeartWare Ventricular Assist Device (HVAD) System
Product code: 1104
Serial numbers: HW36028, HW36033, HW36126, HW36749, HW36851, HW36904, HW37237
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 |
24/08/2023 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic is providing a follow-up to December 2020, May 2021, December 2021, and October 2022 communications titled " Urgent Hazard Alert” (RC-2020-RN-01496-1 and RC-2022-RN-01316-1), where Medtronic communicated that an identified subpopulation (defined as subgroups1 and 2) of HeartWare Ventricular Assist Device (HVAD) Systems may experience a delay to restart or failure to restart at a higher rate than the overall population of HVAD Systems.
Medtronic has identified an additional subgroup population, subgroup 3. Medtronic is sending this communication to all clinicians with patients currently on HVAD support.
This issue does not cause a running HVAD pump to stop; rather, the pump may fail to restart after a pump stop event. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Surgeons are to discuss this information with their patients and to follow the Patient Management Recommendations provided in the customer letter.
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.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
0478 486 782 - arthur.preovolos@medtronic.com - Arthur Preovolos, Medtronic |