Medtronic Australasia Pty Ltd — MyCareLink Relay Home Communicator

PRA number


Published date

Product description

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)
Photograph of MyCareLink Relay Home Communicator
Identifying features

Other identifying numbers

Product Code 24960

Reasons the product is 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.

The hazards to consumers

If incomplete or misleading information is used to make treatment decisions this may lead to insufficient/inappropriate medical intervention causing serious health implications.

What consumers should do

Medtronic will contact affected users in writing, by phone and by automated call messages, where Medtronic network logs indicate a lack of connectivity after July 17, 2020.

Consumers are instructed to power cycle the monitor to update the communication protocols. If the user has already completed a power cycle after July 17 they do not need to take any action.

For further information, please contact Medtronic Customer Service by phone on 1800 644 128.

Where the product was sold

New South Wales
South Australia
Western Australia

Responsible regulator

Therapeutic Goods Administration is the responsible regulator for this recall.

Product category

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