| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01090-1 |
| Product Name/Description |
HeartWare Ventricular Assist Device (HVAD) System
HeartWare HVAD Pump Implant Kit
Model Number: 1104
Serial Number: Serial numbers lower than HW25838
ARTG Number: 181875 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
30/08/2016 |
| Responsible Entity |
|
| Reason/Issue |
HeartWare have identified that specified implant kit pumps may be more susceptible to electrical faults (and connection failures) if the driveline that connects the pump to the controller becomes contaminated. Contamination can occur during the implant procedure or post operatively from fluid ingress into the driveline, and occurs most often in the first 30 days post implant. Potential risks include interruption of circulatory support due to a pump stop.
The reported complaint rate for this contamination is approximately 5.0% of all units sold; however, the actual occurrence rate of serious injury associated with the failure is approximately 1.06%. The majority of reported injuries were categorised as serious due to prophylactic hospitalisation for the cleaning procedure with or without associated medical intervention.
HeartWare has implemented manufacturing process improvements to prevent driveline connector contamination in new implant kits. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
HeartWare is advising clincians that patients with implanted devices that experience electrical faults due to driveline connector contamination should see a medium alert on their controller display. In this case, the clinician should contact their HeartWare representative promptly to schedule a driveline connector cleaning procedure by a qualified HeartWare technician, as described in HeartWare Ventricular Assist System Instructions for Use, section 3.24. Do not attempt to repair or service any components of the HeartWare System.
For devices that have not been implanted, clinicians are advised to identify affected product with HeartWare, who will provide replacement devices and arrange for the return of the affected product. This action has been closed-out on 04/05/2017. |
| Contact Information |
02 8935 9400 - HeartWare |