Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 19644 |
| Brand Name: | HeartWare Vetricular Assist Device AC Adapters and batteries |
| Model: | |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Health New Zealand - Te Whatu Ora 9 Ruskin Street Parnell Auckland 1052 |
| Contact Information: | |
| Manufacturer: | HeartWare International Inc |
| Issue: | As part of HeartWare's ongoing product performance monitoring, we have reviewed certain complaints related to the HVAD® System and are distributing this notice to announce (i) a voluntary recall of AC Adaptors designed for 220-volt power grids; and (ii) a voluntary recall of certain older batteries more likely to exhibit deterioration of battery capacity. HeartWare believes that these actions will help reduce the occurrence of avoidable injuries as patients remain on the device for increasingly long periods of time. New Field Action - DEC2015A (HVAD Controller AC Adaptors): o HeartWare FSCA DEC2015A is assigned to product Code: 1430XX; Serial Numbers: CAC000001 to CAC005796; Reason: HeartWare AC Adapters are vulnerable to power grid surges above 220 volts. |
| Recall action type: | Alert |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 14/1/2016 |
