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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-01009-1
Product Name/Description	Medtronic MyCareLink Remote Monitors Models: 24950, 25000 ARTG Numbers: 215442, 283843 and 235570
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	10/08/2017
Responsible Entity	Medtronic Australasia Pty Ltd
Reason/Issue	Medtronic is updating the Instructions For Use (IFU) for Medtronic MyCareLink Remote Monitors related to patients monitored on the Medtronic CareLink Network with two (2) or more implanted Medtronic heart devices. If a patient has multiple devices, there are potential impacts on the ability to remotely monitor that patient’s heart devices. These potential impacts could lead to missed CareAlert notifications or device reports. Medtronic does not recommend the use of remote monitoring for patients with multiple implanted Medtronic heart devices and clinicians should take this into account when implanting an additional Medtronic heart device or preparing a patient for remote monitoring. For example, if a Medtronic pacemaker is implanted in a patient with an existing Reveal LINQTM Insertable Cardiac Monitor (ICM), it may not be possible to monitor either device remotely.
Recall Action	Recall for Product Correction
Recall Action Instructions	Medtronic does not recommend the use of remote monitoring for patients with multiple implanted Medtronic heart devices and clinicians should take this into account when implanting an additional Medtronic heart device1 or preparing a patient for remote monitoring. This action has been reviewed and is considered complete in accordance with the requirements of the URPTG.
Contact Information	02 9857 9000 - Medtronic