LUX-Dx II™ 60M302-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 00802526620713), received between Oct 30, 2024 and Sep 28, 2026 — classified as 53 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (29 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Mar 30, 2026Class IIOpen, 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.

   Z-2048-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 77 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026False Negative Result; Data Problem

  It was reported that the Insertable Cardiac Monitor (ICM) did not record any AF events. Technical Service reviewed the case with the representative, who inquired why no AF events were recorded despite reported AF burden episodes. AF detection was programmed to 4 minutes, and no recent programming changes were identified. It is possible that the episodes did not meet the programmed detection criteria. Engineering reviewed the case and determined that the missing episode was most likely associated with unrecoverable payload failures. The ICM remains in service, and no adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910575 ↗
• MalfunctionSep 25, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50892559 ↗
• InjurySep 2, 2026Premature Discharge of Battery

  It was reported that an Insertable Cardiac Monitor (ICM) experienced premature battery depletion, with the device reaching replacement criteria after approximately 18 months, which is shorter than the expected device longevity. It was reported that the patient was wearing a magnet around the neck during the implant period. Technical Services discussed that prolonged exposure to a magnet can place the ICM into a high-power interrogation state, resulting in increased battery consumption and potentially reduced battery longevity. Based on the available information, chronic magnet exposure is considered a likely contributing factor to the shortened battery longevity; however, a direct causal relationship could not be definitively confirmed. The ICM was explanted and replaced with a new ICM of the same model. The ICM returned for analysis. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50566377 ↗
• MalfunctionAug 14, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50256054 ↗
• MalfunctionAug 12, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50229895 ↗
• InjuryAug 12, 2026Communication or Transmission Problem

  It was reported that a field representative contacted Technical Services (TS) because neither the clinic mobile monitor (CMM) nor the tablet could connect to the Insertable Cardiac Monitor (ICM). Multiple troubleshooting steps were performed, including use of a magnet, CMM and tablet restarts, Bluetooth reset attempts, network verification, and verification of myLUX application settings and connectivity. The ICM could be seen and felt, and no environmental factors that could have affected the ICM were identified. All interrogation methods failed to establish communication with the ICM. The issue remained unresolved, and TS indicated that the patient would likely require an ICM replacement procedure, with the representative coordinating next steps with the physician.Additional information from the representative indicated that no formal action plans have been established at this time.Additional information indicates that this ICM was explanted and replaced with a new ICM device. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50223050 ↗
• MalfunctionJul 21, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25898505 ↗
• InjuryJul 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT STATED THE INSERTABLE CARDIAC MONITOR (ICM) HAD COME OUT AND WAS DISPOSED OF. THE PATIENT INDICATED THAT THE ICM CONTINUED TO CONNECT TO THE MYLUX APPLICATION AND WAS ADVISED THAT THIS COULD OCCUR. THE PHYSICIAN WAS AWARE OF THE SITUATION, AND PLANS WERE MADE FOR DEVICE REIMPLANTATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Wound Dehiscence

  MAUDE report 25894786 ↗
• MalfunctionJul 17, 2026Nonstandard Device

  IT WAS REPORTED THAT THERE WERE NO FIELD ALLEGATIONS MADE AGAINST THE PERFORMANCE OF THIS INSERTABLE CARDIAC MONITOR (ICM) DEVICE. THE DEVICE WAS RETURNED, AND DEVICE ANALYSIS WAS COMPLETED. PATIENT INFORMATION UNKNOWNS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25851187 ↗
• MalfunctionJul 7, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT SETUP USING A PATIENT PERSONAL PHONE AND PATIENT MOBILE MONITOR (PMM) FAILED IN THE CLINIC. TECHNICAL SERVICES RECOMMENDED TO RETRY PMM SETUP AFTER THE PAIRING WITH THE PATIENT PERSONAL PHONE WAS RELEASED, AND THE REPRESENTATIVE ASSISTED THE PATIENT WITH THE SETUP PROCESS. DURING A LATER REVIEW, THE REPRESENTATIVE SUCCESSFULLY CONNECTED TO THE INSERTABLE CARDIAC MONITOR (ICM) USING CLINIC ASSIST, WHERE A RED SCREEN ALERT INDICATED THAT MONITORING HAD BEEN DISABLED DUE TO AN ICM MALFUNCTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICM REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25741933 ↗
• InjuryJun 29, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THIS INSERTABLE CARDIAC MONITOR (ICM) MONITORING WAS DISABLE DUE TO ICM BEING AT END OF SERVICE (EOS). IT WAS INDICATED THAT DEVICE REPLACEMENT IS NEEDED TO CONTINUE MONITORING AND RETURN ORIGINAL ICM FOR ANALYSIS. THE ICM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25654035 ↗
• MalfunctionJun 24, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE BOSTON SCIENTIFIC FIELD REPRESENTATIVE ATTEMPTED TO INTERROGATE THE INSERTABLE CARDIAC MONITOR (ICM) USING THE CLINIC MOBILE MONITOR BUT WAS UNABLE TO ACTIVATE THE ICM WITH THE MAGNET. THE ICM HAD ALREADY BEEN UNPAIRED FROM BLUETOOTH SETTINGS. TECHNICAL SERVICES REVIEWED THE CASE AND IDENTIFIED INSTABILITY AND DECLINE IN BATTERY VOLTAGE OF THE ICM, SUGGESTING POSSIBLE FULL BATTERY DEPLETION. A DEVICE REPLACEMENT WAS RECOMMENDED AND RETURN OF THE ICM WAS ADVISED FOR FURTHER ANALYSIS. THE REPRESENTATIVE PLANNED TO COORDINATE NEXT STEPS WITH THE CLINIC. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICM REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25612025 ↗
• MalfunctionJun 8, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT A CALL WAS RECEIVED FROM THE CLINIC WITH THE PATIENT, AS A MESSAGE IN THE MYLUX APP INDICATED TO CONTACT THE CLINIC ABOUT MONITORING. IT WAS IDENTIFIED THAT MONITORING WAS DISABLED BECAUSE THE INSERTABLE CARDIAC MONITOR (ICM) REACHED END OF SERVICE DUE TO BATTERY DEPLETION. THE ICM DEVICE REACHED BATTERY DEPLETION EARLIER THAN EXPECTED BASED ON THE IMPLANT DURATION, SUGGESTING POSSIBLE PREMATURE BATTERY DEPLETION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICM REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25436445 ↗
• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE INSERTABLE CARDIAC MONITOR (ICM) DEVICE IMPLANT SITE. DUE TO THIS REASON, THE ICM DEVICE WAS EXPLANTED FROM THE PATIENT. THE EXPLANT PROCEDURE WAS PERFORMED WITH THE PATIENT BEING UNDER MODERATE CONSCIOUS SEDATION; NO PATIENT COMPLICATIONS WERE REPORTED. LOCAL ANESTHESIA WAS ALSO APPLIED, AND THE ICM DEVICE WAS SUCCESSFULLY EXPLANTED. THE PATIENT WAS SUBSEQUENTLY DISCHARGED FROM THE HOSPITAL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE EXPLANTED ICM DEVICE WAS RETURNED AND IS UNDERGOING A DETAILED ANALYSIS AT THIS TIME.

  Patient problems: Implant Pain

  MAUDE report 25153692 ↗
• MalfunctionApr 30, 2026Failure to Read Input Signal; Insufficient Device Problem Information

  IT WAS REPORTED THAT, AN INSERTABLE CARDIAC MONITOR DEVICE INSERTION WAS ATTEMPTED, BUT THE PROCEDURE COULD NOT BE COMPLETED FOR AN UNSPECIFIED REASON. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25050504 ↗
• MalfunctionApr 28, 2026Premature Discharge of Battery

  It was reported that this insertable cardiac monitor (ICM) reached the Recommended Replacement Time (RRT). It was indicated that the ICM was displaying signs of premature battery depletion as the voltage started to drop unexpectedly. It was advised to return the device for detailed analysis. The ICM remains in service and no adverse patient effects were reported.The ICM has been explanted. A new ICM has been implanted. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25017807 ↗
• MalfunctionApr 16, 2026Data Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INSERTABLE CARDIAC MONITOR (ICM) HAD A PVC BURDEN MONITORING ENABLE APPROXIMATELY 4 MONTHS AGO. HOWEVER, SUBSEQUENT TRANSMISSIONS CONTINUED TO SHOW THAT PVC BURDEN MONITOR WAS OFF. BOSTON SCIENTIFIC TECHNICAL SERVICES CONFIRMED THAT PVC MONITORING WAS PROGRAMMED AND ACCEPTED BY THE ICM. HOWEVER, A DISCREPANCY WAS NOTED BETWEEN THE PROGRAMMED SETTINGS AND WHAT WAS BEEN DISPLAYED IN THE LATITUDE CLARITY SYSTEM. THE ISSUE REMAINS UNRESOLVED AND IT IS UNDER INVESTIGATION. THE ICM REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION INDICATED THAT PROGRAMMING FOR PVC DID NOT TAKE EFFECT AT THE TIME OF THE INITIAL ACTIVATION DUE TO A SYSTEM ISSUE. IT WAS CONFIRMED THAT MONITORING FOR PVC HAS BEEN ACTIVATED SINCE THE SETTING WAS MODIFIED BACK WHEN THE INITIAL ALLEGATION WAS MADE. THE ICM REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24896010 ↗
• MalfunctionMar 31, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING A PRE-IMPLANT CHECK, THE PHYSICIAN NOTED THERE WAS A MESSAGE THAT INDICATED THERE WAS AN INSERTABLE CARDIAC MONITOR (ICM) DEVICE ISSUE AND THAT THE MONITOR WAS DISABLED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THIS ICM DEVICE SHOULD NOT BE IMPLANTED, AND THAT IT SHOULD BE RETURNED FOR ANALYSIS. THERE WAS NO REPORTED PATIENT INVOLVEMENT. THIS ICM DEVICE HAS BEEN RETURNED AND ANALYSIS WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24748841 ↗
• InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT THIS INSERTABLE CARDIAC MONITOR (ICM) WAS EXPLANTED DUE TO INFECTION. NO NEW DEVICE WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 24690021 ↗
• InjuryMar 25, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS INSERTABLE CARDIAC MONITOR (ICM) WAS NOT CONNECTING. IT WAS INDICATED THAT THE MONITORING IS DISABLE DUE TO POSSIBLE DEVICE MALFUNCTION. THE PATIENT WAS REFERRED TO THE CLINIC. THE ICM REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24690013 ↗
• MalfunctionMar 23, 2026Data Problem

  IT WAS REPORTED THAT DURING A RETROSPECTIVE REVIEW OF DEVICE DATA, IT WAS IDENTIFIED THAT THIS INSERTABLE CARDIAC MONITOR (ICM) HAD THE PREMATURE VENTRICULAR CONTRACTION (PVC) BURDEN MONITORING ENABLED. HOWEVER, A TRANSMISSION SHOWED THAT THE PVC BURDEN MONITOR WAS OFF. IT WAS DETERMINED THAT A DISCREPANCY IS PRESENT BETWEEN THE PROGRAMMED SETTINGS AND WHAT HAS BEEN DISPLAYED IN THE LATITUDE CLARITY DATA MANAGEMENT SYSTEM. NO OTHER INFORMATION WAS PROVIDED. THIS DEVICE REMAINS IN SERVICE. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24669244 ↗
• InjuryMar 16, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT A REPRESENTATIVE CALLED IN REGARDING AN INSERTABLE CARDIAC MONITOR (ICM). THE ICM HAD BEEN REPLACED, SINCE IT REACHED THE RECOMMENDED REPLACEMENT TIME (RRT) AFTER BEING IMPLANTED APPROXIMATELY 2 YEARS AGO AND BSC REPRESENTATIVE CONFIRMED PREMATURE BATTERY DEPLETION; NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE ICM WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24613104 ↗
• InjuryMar 4, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A PERSISTENT CONNECTION ISSUE AND WAS UNABLE TO ESTABLISH COMMUNICATION WITH THE INSERTABLE CARDIAC MONITOR (ICM). THE PATIENT ATTEMPTED SEVERAL TROUBLESHOOTING STEPS, INCLUDING TURNING OFF WI-FI, PERFORMING PATIENT INITIATED INTERROGATIONS (PII), FORGETTING AND RE-ADDING THE DEVICE CONNECTION, AND REINSTALLING THE MYLUX APPLICATION. DESPITE THESE ACTIONS AND ENSURING ALL PERMISSIONS WERE ENABLED, THE ICM STILL DID NOT PAIR WITH THE PATIENT'S PHONE. THE ISSUE REMAINED UNRESOLVED, AND THE PATIENT WAS INSTRUCTED TO RETRY LATER OR CONTACT THE CLINIC. ADDITIONAL SETUP ATTEMPTS USING THE PATIENT'S PERSONAL PHONE AND A CLINIC MOBILE MONITOR (CMM) WERE ALSO UNSUCCESSFUL. HEALTHCARE PROFESSIONALS TRIED DIFFERENT MAGNETS AND CONFIRMED THE IMPLANT COULD BE FELT, BUT PAIRING CONTINUED TO FAIL. IT WAS RECOMMENDED TO VERIFY THAT THE CMM IN USE WAS ACTIVE AND, IF POSSIBLE, TO ATTEMPT PAIRING WITH A PATIENT MOBILE MONITOR (PMM). THE REPRESENTATIVE CONTINUED TO SUPPORT THE CLINIC, AND IT WAS LATER CONFIRMED THAT THE ICM WAS EXPLANTED DUE TO THE DEVICE PERFORMANCE ISSUE. A NEW ICM WAS IMPLANTED IN THE PATIENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24507069 ↗
• InjuryMar 2, 2026Signal Artifact/Noise; Communication or Transmission Problem

  IT WAS REPORTED THAT THE CLINIC BEING UNABLE TO ESTABLISH COMMUNICATION WITH THE INSERTABLE CARDIAC MONITOR (ICM) USING EITHER IN-CLINIC EQUIPMENT OR A BRING-YOUR-OWN-DEVICE (BYOD). DESPITE MULTIPLE ATTEMPTS BY TECHNICAL SERVICE (TS) TO INITIATE A PATIENT-TRIGGERED INTERACTION, THE ICM DID NOT RESPOND, AND NO HAPTIC FEEDBACK WAS NOTED. THE CLINIC ALSO ATTEMPTED TO ACTIVATE THE ICM USING A MAGNET, BUT THIS WAS UNSUCCESSFUL. ALTHOUGH THE BYOD APP SHOWED ACTIVE PROVISIONING AND NORMAL FUNCTIONALITY, AND THE MOBILE PHONE REMAINED CONNECTED TO THE SYSTEM, THE PRESENTING ELECTROGRAM RECEIVED CONSISTED PRIMARILY OF SIGNAL NOISE. EARLIER PRESENTING ELECTROGRAMS WERE THE LAST TO DEMONSTRATE IDENTIFIABLE CARDIAC ACTIVITY. THE ICM DID NOT MIGRATE, AND THE USER OF THE BYOD AND APP WAS UNABLE TO PERFORM SUCCESSFUL MANUAL TRANSMISSIONS. BASED ON THE REPEATED INABILITY TO WAKE OR COMMUNICATE WITH THE SYSTEM AND THE DEGRADED PRESENTING ELECTROGRAM, TS RECOMMENDED REPLACING THE ICM AND RETURNING IT FOR ANALYSIS. THE ICM REMAINS IN SERVICE, WITH NO REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24482612 ↗
• MalfunctionFeb 27, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING AN INSERTABLE CARDIAC MONITOR (ICM) DEVICE IMPLANT PROCEDURE, INITIALLY, IT WAS POSSIBLE TO CONNECT WITH THIS ICM DEVICE. HOWEVER, AFTER THE ICM DEVICE WAS IMPLANTED, A MESSAGE WAS DISPLAYED, INDICATING THERE WAS AN ISSUE WITH THE ICM DEVICE. DUE TO THIS REASON, THE DEVICE WAS REMOVED FROM THE PATIENT, PRIOR TO POCKET CLOSURE, AND A DIFFERENT ICM DEVICE WAS SUCCESSFULLY IMPLANTED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE FIRST ICM DEVICE HAS BEEN RETURNED AND ANALYSIS HAS BEEN COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24469803 ↗