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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00644-1
Product Name/Description Medtronic Reveal LINQ Insertable Cardiac Monitor (ICM)

Model LNQ11

ARTG Number: 218791
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 7/06/2016
Responsible Entity Medtronic Australasia Pty Ltd
Reason/Issue In February 2016, Medtronic issued a Medical Device Hazard Alert communication that indicated Medtronic Reveal LINQ Insertable Cardiac Monitors (ICMs) could experience a performance issue that affects the Recommended Replacement Time (RRT) alert. This original communication named Phase 1, also explained that Medtronic was awaiting a software update to address this issue.

Medtronic has now developed the necessary software and is ready to begin applying this update to all Reveal LINQ ICMs which constitutes Phase 2 of the alert.

Once installed, this software update will reset RRT & End of Service (EOS) status and re-enable wireless transmissions for devices that have experienced premature RRT /EOS. The update will also prevent the occurrence of premature RRT alerts due to this issue. Refer to the original communication for additional details (RC-2016-RN-00202-1).
Recall Action Recall for Product Correction
Recall Action Instructions Medtronic will be providing a software update as a permanent correction. For more information, please see This action has been closed-out on 17/02/2017.
Contact Information 03 8851 1022 - Medtronic