Medtronic Australasia Pty Ltd — Guardian Connect iOS App CSS7200

PRA number


Published date

Product description

Guardian Connect App - Connectivity to Carelink Personal Software
Guardian Connect iOS App: CSS7200

The Guardian Connect App is used as the primary display on a personal mobile device for monitoring of blood glucose levels , in persons with diabetes, for the purpose of improving diabetes management.

ARTG 276924
(Medtronic Australasia Pty Ltd - Information system software, application program, patient record)

Reasons the product is recalled

Reports of data connectivity disruptions to the CareLink software.  

As a result, the following disruptions may occur:

  • Care partners may not receive SMS alerts from the Guardian Connect app;
  • Care partner remote access monitoring in the CareLink Connect web app may show data gaps; or
  • Users may see data gaps in CareLink reports.

Normal use of the Guardian Connect app is not impacted and users will still be able to view CGM data and receive alerts in the Guardian Connect app.

The hazards to consumers

If inaccurate blood glucose information is used to determine the insulin dose or make treatment decisions, this may lead to incorrect dosing decisions which can lead to serious health complications.

What consumers should do

Medtronic will contact affected consumers in writing. Consumers should follow the instructions within the letter provided by Medtronic to identify any affected devices and to correct the issue.

Consumers are advised to uninstall the Guardian Connect app, unpair the transmitter from the mobile device and re-install the Guardian Connect app.

For further information, please contact Medtronic Customer Service by phone on 1800 777 808.

Traders who sold this product

App Store
Google Play Store

Where the product was sold


Responsible regulator

Therapeutic Goods Administration is the responsible regulator for this recall.

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