| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01323-1 |
| Product Name/Description |
HeartWare Ventricular Assist System (intended for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end stage heart failure)
Catalogue Numbers: 1100, 1101, 1102, 1103, 1104 & 1205
Serial Numbers: HW001 to HW11215 and HW20001 to HW20296
ARTG Number: 181875 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
18/12/2013 |
| Responsible Entity |
|
| Reason/Issue |
Subsequent to a Urgent Recall for Product Correction (TGA Ref: RC-2013-RN-00126-1) of HVAD Pump's driveline connector housing become partially or fully separated from the front portion of the driveline connector, HeartWare have identified an alternative failure mechanism. In 8 cases, customers have reported that the locking mechanism of the driveline connector has failed to engage. There have been no reports of injury. HeartWare has made changes to the manufacturing procedures to address this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Heartware is advising users that should the driveline disconnect from the controller, push the driveline connector back into the controller immediately and contact Heartware for repair..
Heartware is advising clinicians to inspect patient's driveline connector as described in the provided technical bulletin for proper locking. For already implanted patients, please arrange a follow up visit at the earliest convenience to check the patient's driveline connector. If the locking mechanism of the driveline connector is found to have failed to engage, please push the connector back into the controller and contact Heartware for repair. |
| Contact Information |
02 8078 6164 - HeartWare Representative |