LUX-Dx Insertable Cardiac Monitor Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · Insertable Cardiac Monitor (ICM/ILR) · First cleared Sep 2025
Total Reports
570
Reports (30d)
4
Active Signals
2
Open Recalls
6
What the reports describe · Claripulse analysis
Most commonly reported problems
Product Performance Issue Leading to Explant
explanted, insertable cardiac, adverse, effects, service
7
reports
Noise Complicating Episode Detection
fibrillation, noise, atrial, episodes, false
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Regulatory
FDA recalls for this device
Aug 6, 2026 · Open, Classified
There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical evaluation or therapeutic intervention of an atrial arrhythmia.
Aug 6, 2026 · Open, Classified
There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical evaluation or therapeutic intervention of an atrial arrhythmia.
Aug 6, 2026 · Open, Classified
There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical evaluation or therapeutic intervention of an atrial arrhythmia.
Mar 30, 2026 · Open, Classified
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.
Mar 30, 2026 · Open, Classified
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.
Sep 6, 2024 · Open, Classified
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.
Evidence
Related research
Safety, performance, and remote programming utilization of an insertable cardiac monitor: The LUX-Dx PERFORM study
Mark Richards, et al. · Heart Rhythm O2 · 2026
Preliminary results from the LUX-Dx insertable cardiac monitor remote programming and performance (LUX-Dx PERFORM) study.
Stolen C, et al. · Clinical cardiology · 2022
Citations indexed from PubMed.
Keep exploring
Related devices in CRM
CAPSUREFIX Novus
MEDTRONIC, INC. · 46,344 reports
Sprint Quattro Secure S MRI SureScan
MEDTRONIC, INC. · 39,133 reports
EMBLEM S-ICD
BOSTON SCIENTIFIC CORPORATION · 39,062 reports
CapSureFix Novus MRI SureScan
MEDTRONIC, INC. · 29,710 reports
Durata
ABBOTT (ST. JUDE MEDICAL) · 20,458 reports
Quadra Assura MP
ABBOTT (ST. JUDE MEDICAL) · 10,671 reports
Want automated safety signal detection?
Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 2 active signals detected right now.
Get Early AccessUnderstanding this data