MyCareLink Relay Home Communicator
Published 14 September 2020
Product
MyCareLink Relay Home Communicator Product code: 24960 All serial numbers The MyCareLink Relay Home Communicator sends data from an implanted heart device to medical clinicians. ARTG 313825 (Medtronic Australasia Pty Ltd - Cardiac pulse generator reader, home-use)
Why it was recalled
A software update on 17 July 2020 caused a data connectivity disruption to the MyCarelink software. As a result data transmissions, including CareAlerts, are disabled between the Communicator and the CareLink Network. This issue results in the inability for a Relay communicator to transmit implanted device data to the CareLink Network and persists until the Relay is power cycled for any reason. There is no impact to users implanted device or data from that device.
Hazard
If incomplete or misleading information is used to make treatment decisions this may lead to insufficient/inappropriate medical intervention causing serious health implications.
Source: Product Safety Australia. RecallMatch AU provides a screening summary and is independent of the ACCC.