| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00126-1 |
| 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)
Product Code: 1100, 1101, 1102, 1104, 1205
Serial Numbers: HW001 to HW3827 and HW10000 to HW10675
ARTG Number: 181875 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
8/02/2013 |
| Responsible Entity |
|
| Reason/Issue |
There is potential for the rear portion of the HVAD Pump's driveline connector housing partially or fully separating from the front portion of the driveline connector. If unattended, the electrical connection to the controller could be affected and loss of mechanical circulatory support may occur. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
HeartWare are advising medical practitioners to inspect the patients drive line connector at each routine clinic visit.
If the rear portion of the driveline connector housing is partially separated from the front portion, hand tighten the front and rear portions together. Contact your HeartWare Representative to arrange for an inspection and permanent repair by a HeartWare Clinical Engineer.
If the driveline connector housing is completely separated secure the driveline connector housing to the controller with a splint to maintain a secure connection until a repair can occur. Where the connector/controller connection is secured by splinting the controller and connector with tongue depressors and electrical tape. Contact your HeartWare Representative to arrange for an inspection and permanent repair by a HeartWare Clinical Engineer.
Further information can be found ont he TAG website at https://www.tga.gov.au/alert/heartware-ventricular-assist-system |
| Contact Information |
02 8078 6164 - Heartware |