Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 22073 |
| Brand Name: | Heartware Ventricular Assist Device (HVAD) Controllers |
| Model: | |
| Affected: | Serial numbers lower than CON300000 |
| Software version: | |
| Recalling Organisation: | Medtronic New Zealand Limited Unit 16 Mezzanine Level 5 Gloucester Park Road Onehunga AUCKLAND |
| Contact Information: | 0800 377 807 |
| Manufacturer: | HeartWare Inc |
| Brand Name: | Heartware Ventricular Assist Device (HVAD) DC Adapters |
| Model: | 1435 |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Medtronic New Zealand Limited Unit 16 Mezzanine Level 5 Gloucester Park Road Onehunga AUCKLAND |
| Contact Information: | 0800 377 807 |
| Manufacturer: | HeartWare Inc |
| Issue: | As described in previous Hazard Alerts from April 2015 and April 2016, there was the potential for the following safety issues associated with the current HeartWare HVAD System Controller, including: 1. Worn alignment guides, potentially resulting in damaged connector pins. 2. Internal double disconnect (no power) alarm battery failure, which could prevent the controller from Sounding an alarm in the event of a complete interruption of power. 3. Loose power and data connectors, which could allow fluid ingress With the introduction of the updated HVAD Controller, also referred to as Controller 2.0, Medtronic is initiating removal procedures for previous generation HeartWare HVAD Controllers and all HeartWare DC Adapters, 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. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Healthcare Professional |
| Date Commenced: | 10/10/2017 |
