FDA Device recall Z-1249-2016
Reveal LINQ insertable Cardiac Monitor, Model LNQ11
- FDA Device
- Class II
- terminated
- Published 2016-04-06
On 2016-04-06 the FDA classified a Class II recall of Reveal LINQ insertable Cardiac Monitor, Model LNQ11 by Medtronic, citing medtronic has identified an issue with the sensitivity of an algorithm used in the Reveal LINQ ICM that may prematurely trigger the Recommended Replacement Time (RRT) alert in som….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1249-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-02-23 |
| Published | 2016-04-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medtronic |
| Distribution | US |
Product
Reveal LINQ insertable Cardiac Monitor, Model LNQ11. Monitors subcutaneous ECG continuously.
Reason
Medtronic has identified an issue with the sensitivity of an algorithm used in the Reveal LINQ ICM that may prematurely trigger the Recommended Replacement Time (RRT) alert in some devices. Battery capacity is not affected and the device will continue to support data collection and manual data transmissions. As part of the normal behavior of the device, 30 days after RRT status is reached, Reveal
Identifiers
| code_info | All Reveal LINQ ICM, Model LNQ11 serial numbers are impacted. Medtronic continues to manufacture and distribute Reveal Ll NQ devices. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1249-2016%22
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