Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2024-RN-00552-1
Product Name/Description	Medtronic CareLink 2090 Programmer Autonomous Cursors PRGM 2090 PROGRAMMER-PORTABLE CRM Model number: 2090 Serial Number: Devices with serial number prefixes PKK0 and PKK1 PROGRAMMER 2090W TELEMETRY C Model number: 2090W Serial number: Devices with serial number prefixes PKK0 and PKK1 ARTG 116038 (Medtronic Australasia Pty Ltd - Medtronic carelink programmer, model 2090 - Pacemaker programmer)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	10/07/2024
Responsible Entity	Medtronic Australasia Pty Ltd
Reason/Issue	Medtronic CareLink 2090 programmers with serial number prefixes PKK0 and PKK1 have the potential for autonomous cursor motion when Finger Touchscreen capability is enabled by software version 3.2 or higher. Through 11 June 2024, Medtronic has received 23 reports of autonomous cursor behaviour, with 2 reports of unintended therapy delivered when the programmer was not under the control of trained personnel during a patient session. There have been no reports of permanent harm or death associated with this behaviour.
Recall Action	Product Defect Correction
Recall Action Instructions	Medtronic will contact affected customers to assist with the software updates and assessing the proper function of the affected devices. If needed, Medtronic representatives will assist with returning programmers for repair or replacement.
Contact Information	0404 824 075 - Ilan Fogel, Medtronic