| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2022-RN-01316-1 |
| Product Name/Description |
HeartWare (HVAD) System
Model number: 1104
Serial number: HW35315
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 |
21/10/2022 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic is providing a letter as a follow-up to previous "Urgent Hazard Alert” RC-2020-RN-01496-1.
There are no new HVAD devices identified, Medtronic is sending this communication to all clinicians with patients currently on support.
Medtronic is providing additional recommendations for all patients on support (including subgroup 1 and 2). |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Medtronic recommands the following as outlined in the customer letter (will be provided only to the impacted customers by Medtronic):
- Surgeons are advised to notify implanted customers to follow the additional Patient Management Recommendations provided in the customer letter.
- Reinforce the current Instructions for Use to patients and staff;
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
0478 486 782 - Arthur - Medtronic |