Recall Z-1249-2016— Medtronic Inc.
Class II · Terminated
Class II FDA medical device recall by Medtronic Inc., initiated 2016-02-23, terminated 2017-09-25. It names one FDA 510(k) clearance: K132649. 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.
- Recalling firm
- Medtronic Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-02-23
- Terminated
- 2017-09-25
- Firm location
- Saint Paul, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Reveal LINQ insertable Cardiac Monitor, Model LNQ11. Monitors subcutaneous ECG continuously.
Reason for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.