Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
FDA adverse event reports and recall history for recorder, event, implantable cardiac, (with arrhythmia detection) (product code MXD), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 12,451
- Deaths
- 4
- Injuries
- 2,147
- Malfunctions
- 10,300
Reports per year
Source: FDA adverse event reports by year received, 2001–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2026-05-01Open, ClassifiedUnder Investigation by firm
LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5
For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location.
- 2026-05-01Open, ClassifiedUnder Investigation by firm
LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Version 7.5, or SERVER SW LATITUDE DRAGON AU (Australia/New Zealand), Model 6448, Version 7.5
For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location.
- 2024-10-25Open, ClassifiedUnder Investigation by firm
Boston Scientific myLUX Patient Application for an Apple Mobile device, Model Number 2939, Version 2.0.101, 2.0.110, cardiac monitor application.
Patients using the Model 2939 myLUX Patient Application on their Apple mobile device (e.g., iPhone) may not be transmitting data from their Insertable Cardiac Monitor to the LATITUDE Clarity website.
- 2023-12-01Open, ClassifiedProcess change control
ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor
It may create the potential for amplified noise and/or overall signal reduction of the ICM, which may interfere with intended recordings of heart rhythms. This noise pattern is different from occasional noise due to device position/migration, patient activity, or external electromagnetic interference.
- 2021-07-14Open, ClassifiedSoftware design
Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO Rx Only
Device fail to detect Brady episodes, Pause (Asystole) episodes and PVC's after a ride-through POR reset.
- TerminatedNonconforming Material/Component
LINQ II Insertable Cardiac Monitor
Devices may lose functionality due to susceptibility to moisture ingress.
- Open, ClassifiedSoftware design
Medtronic Reveal LINQ LNQ11 / PA96000
Reveal LINQ with TruRhythm ICMs, that undergo a partial electrical reset appear to be programmed "ON", but are no longer able to detect and report Brady and Pause events to clinicians.
Monitor recorder, event, implantable cardiac, (with arrhythmia detection) automatically
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