| 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 |
|
| 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 https://www.tga.gov.au/alert/medtronic-reveal-linq-insertable-cardiac-monitor. This action has been closed-out on 17/02/2017. |
| Contact Information |
03 8851 1022 - Medtronic |