Recall Z-1249-2016 ยท DSI Detector And Alarm, Arrhythmia
Medtronic Inc.
Reveal LINQ insertable Cardiac Monitor, Model LNQ11. Monitors subcutaneous ECG continuously.
| Date | Feb 23, 2016 |
| Status | Terminated |
| 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 |
| Root cause | Software design |
| Action | Consignees in US were hand delivered a Medtronic "Medical Device Correction" letter dated February 2016. The letter was addressed to Physician or Healthcare Professional. The letter described the Issue & Patient Management Guidance. For questions contact your local Medtronic Representative or Medtronic Diagnostic Technical Services at 800-929-4043. Outside the U.S., the letter will be mailed or hand delivered to impacted consignees. |
| Quantity | 189,009 |
| Distribution | Worldwide Distribution-US (nationwide) including DC and the countries of Andorra, Australia, Austria, Belgium, Botswana, Brunei Darussalam, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Faroe Islands , Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, Indonesia, I |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132649 | REVEAL LINQ INSERTABLE CARDIAC MONITOR Medtronic, Inc., Feb 14, 2014 |