Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 17947 |
| Brand Name: | HeartWare Controller |
| Model: | Product Codes: 1400, 1401XX |
| Affected: | Serial Number Range: CON000001 through CON005472 |
| Software version: | |
| Recalling Organisation: | Health New Zealand - Te Whatu Ora 9 Ruskin Street Parnell Auckland 1052 |
| Contact Information: | |
| Manufacturer: | HeartWare International Inc |
| Issue: | A selected range of serial numbers of HeartWare Controllers exhibit a higher susceptibility to electrostatic discharge (ESD) than new Controllers. In 2013 HeartWare advised of the potential for this issue. Since then the manufacturer has received reports of one additional death and one additional serious injury in which ESD may have caused or contributed to data corruption in older Controllers resulting in the loss of commutation to pump motors, which ultimately led to pump stops. |
| Recall action type: | Recall |
| Recall action: | Product to be exchanged |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 6/1/2015 |
