Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 27353 |
| Brand Name: | Heartware - Ventricular Assist System (HVAD) |
| Model: | Controller AC Adapter 1425, 1430 - Controller DC Adapter 1440 - Battery 1650DE - Alarm Adapter 1450 - Monitor Data Cable 1575 -Controller 1400, 1401, 1403, 1407 |
| 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: | The manufacturer is informing users of an upcoming updates to the HVAD™ System Instructions for Use (IFU) and Patient Manual (PM). These updates will (1) provide new information relating to the useful life of the HVAD™ System carrying cases (Waist Pack, Shoulder Pack, and Convertible Patient Pack), (2) clarify the HVAD™ Controller connections, power-up sequence, and notifications, and (3) clarify expected duration of HVADTM System alarms. The following updates are being made to the PM only: (1) provide additional information relating to the care and use instructions for the HVAD™ System carrying cases and (2) provide additional information relating to the HVADTM Controller driveline cover. The full updates to the IFU and PM are attached in Appendix A.2. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 26/2/2021 |
