Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 18489 |
| Brand Name: | Heartware HVAD Pump System |
| Model: | 1100, 1101, 1102, 1104, 1205 |
| Affected: | All systems |
| Software version: | |
| Recalling Organisation: | Health New Zealand - Te Whatu Ora 9 Ruskin Street Parnell Auckland 1052 |
| Contact Information: | |
| Manufacturer: | HeartWare International Inc |
| Issue: | Heartware has issued a hazard alert advising physicians and patients of issues that could impact on the performance of the HVAD pump: 1. Bent/damaged power supply port connector pins 2. Failure of the "no power alarm" in the event both external power sources are lost 3. Abnormal power source switching 4. Driveline outer sheath discolouration and cracking over time 5. Snagging or pulling of the driveline |
| Recall action type: | Alert |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Public Recall |
| Date Commenced: | 15/5/2015 |
