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)
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)
See a list of details to help identify the product.
Reason 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.
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.
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.
Details to help identify the product.
Supplier running the recall
Identifying numbers
Other identifying numbers
Product Code 24960
Where the product was sold
International
New South Wales
Queensland
South Australia
Victoria
Western Australia
Responsible regulators
Regulators are established or appointed by government. They enforce regulations and rules.
Quote PRA number 2020/18556 when contacting a regulator about this recall.
Recall and remedy questions
Contact the Therapeutic Goods Administration if you have:
- a question about the remedy being offered to you by the business that is responsible for managing this recall, or
- concerns about the way the business is managing this recall.