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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-00580-1
Product Name/Description	HeartWare HVAD system Product Codes: 1407XX All HeartWare Controllers affected ARTG Number: 181875
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	11/05/2016
Responsible Entity	Heartware Pty Ltd
Reason/Issue	HeartWare have received reports of loose power and data connectors on the HeartWare Controller, specifically for loose connector ports within the Controller. If a power or data connector becomes loose, controllers could become more vulnerable to water damage, which could lead to internal corrosion, electrical issues, reduced speaker volume and connection failures. In these scenarios, potential risks include: - Interruption of circulatory support due to a pump stop, which could cause serious injury or death - Reduced ability to detect alarms - Loss of communication between the Controller and HeartWare Monitor.
Recall Action	Hazard Alert
Recall Action Instructions	HeartWare is advising the clinicians to: 1. Continue to remind the patients currently supported by the HVAD System to follow all instructions in their Patient Manuals including alarm awareness, water avoidance and carefulness when connecting and disconnecting to power and data sources. 2. At the patients’ regularly-schedule appointments, inspect Controllers for loose connectors by gently pressing on each connector and feeling for atypical movement. Do not press hard on the connectors or they could break. If a loose connector is identified, it is recommended that the affected Controller be replaced with a Controller from inventory and contact the local HeartWare representative. If the affected Controller is the patient’s primary Controller, please use discretion as to whether the risks of a Controller exchange outweigh the risks of a Controller with a loose connector. This action has been closed-out on 22/02/2017.
Contact Information	02 8935 9400 - HeartWare