Home › Device types › MXD
Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
FDA product code MXD · Class 2 · Cardiovascular
39
Registered devices
12,726
Adverse events
10
Recalls
33
510(k) clearances
Devices with this code
myLUX™ patient app — BOSTON SCIENTIFIC CORPORATIONmyLUX™ Patient Kit with mobile device — BOSTON SCIENTIFIC CORPORATIONmyLUX™ Mobile Device — BOSTON SCIENTIFIC CORPORATIONLUX-Dx™ Clinic Assistant app — BOSTON SCIENTIFIC CORPORATIONBioMonitor 2-AF — BIOTRONIK SE & Co. KGAccuRhythm™ AI — MEDTRONIC, INC.BioMonitor IIIm — BIOTRONIK SE & Co. KGBioMonitor — BIOTRONIK SE & Co. KGBioMonitor — BIOTRONIK SE & Co. KGLINQ II™ — MEDTRONIC, INC.CareLink SmartSync™ LINQ II™ Platform Application — MEDTRONIC, INC.LUX-Dx™ Clinic Assistant Kit with mobile device — BOSTON SCIENTIFIC CORPORATIONAccuRhythm™ AI — MEDTRONIC, INC.Reveal LINQ™ — MEDTRONIC, INC.BioMonitor IV — BIOTRONIK SE & Co. KGAccuRhythm™ AI — MEDTRONIC, INC.LUX-Dx II+™ — BOSTON SCIENTIFIC CORPORATIONLINQ II™ — MEDTRONIC, INC.LATITUDE® Clarity — BOSTON SCIENTIFIC CORPORATIONRemote Assistant III — BIOTRONIK SE & Co. KGLUX-Dx™ — BOSTON SCIENTIFIC CORPORATIONReveal LINQ™ — MEDTRONIC, INC.LUX-Dx™ Insertable Cardiac Monitor — BOSTON SCIENTIFIC CORPORATIONLUX-Dx II™ — BOSTON SCIENTIFIC CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-06 | Boston Scientific Corporation | There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed noti |
| 2026-08-06 | Boston Scientific Corporation | There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed noti |
| 2026-08-06 | Boston Scientific Corporation | There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed noti |
| 2026-03-30 | Boston Scientific Corporation | 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 monit |
| 2026-03-30 | Boston Scientific Corporation | 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 monit |
| 2024-09-06 | Boston Scientific Corporation | 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 M |
| 2023-11-03 | Medtronic Inc. | 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 |
| 2022-01-18 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) | Devices may lose functionality due to susceptibility to moisture ingress. |
| 2021-06-01 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) | 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 Pau |
| 2021-05-14 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) | Device fail to detect Brady episodes, Pause (Asystole) episodes and PVC's after a ride-through POR reset. |
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