Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 15885 |
| Brand Name: | HeartWare Ventricular Assist System |
| Model: | 1100, 1101, 1102,1103, 1104 and 1205 |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Health New Zealand - Te Whatu Ora 9 Ruskin Street Parnell Auckland 1052 |
| Contact Information: | |
| Manufacturer: | HeartWare International Inc |
| Issue: | Manufacturer has discovered a failure mechanism arising from improper thread locking technique. In 8 cases customers have reported that the locking mechansim of the driveline connector has failed to engage . Of these 8 reports none has resuklted in any injury. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Healthcare Professional |
| Date Commenced: | 18/12/2013 |
