LUX-Dx™ Insertable Cardiac Monitor M301Recalls & reported problems

Summary

The FDA's MAUDE database contains 478 adverse event reports that list this exact device (DI 00802526607103), received between Dec 18, 2020 and Sep 29, 2026 — classified as 437 injuries, 41 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (87 reports).

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 478 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that monitoring on this Insertable Cardiac Monitor (ICM) was disabled due to a possible device malfunction. The patient was no longer being monitored because the issue could not be resolved with the ICM device. Technical Services recommended replacement of the ICM and return of the explanted device for analysis. No adverse patient effects were reported. This ICM remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933154 ↗
• InjurySep 29, 2026Communication or Transmission Problem

  It was reported that this insertable cardiac monitor (ICM) was explanted as it was unable to be connected with the clinic assistant tablet by the nurse practitioner. The ICM will be returned for analysis. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927645 ↗
• MalfunctionAug 14, 2026Premature Discharge of Battery

  It was reported that this insertable cardiac monitor (ICM) reached the End Of Service (EOS) status after 2 years of being implanted. The ICM remains in service and adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50256080 ↗
• InjuryAug 14, 2026Insufficient Device Problem Information

  It was reported that this insertable cardiac monitor (ICM) was explanted as it no longer worked. No new ICM was implanted. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50255919 ↗
• InjuryJul 20, 2026Insufficient Device Problem Information

  It was reported that the patient with this insertable cardiac monitor (ICM) indicated that the doctor sent them into emergency surgery following a heart tilt table test for a pacemaker. The surgeon put an ICM instead, but this ICM never worked right. The ICM was finally explanted as it never took readings. No new ICM was implanted. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25884590 ↗
• MalfunctionJul 14, 2026Nonstandard Device

  IT WAS REPORTED THAT THE INSERTABLE CARDIAC MONITOR (ICM) WAS RETURNED TO BSC WITH NO INITIAL ALLEGATION. THE ICM WAS RETURNED BSC. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25820444 ↗
• MalfunctionJul 10, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT MONITORING WAS DISABLED DUE TO A SUSPECTED INSERTABLE CARDIAC MONITOR (ICM) DEVICE MALFUNCTION, AND THE PATIENT WAS NOT MONITORED BECAUSE OF AN UNRESOLVED ISSUE WITH THE ICM, INDICATING THAT DEVICE REPLACEMENT WAS INITIALLY CONSIDERED NECESSARY. TECHNICAL SERVICES (TS) REVIEW FOUND THAT THE LATITUDE SYSTEM BRIEFLY REPORTED A BOOTLOADER OPERATING STATE; HOWEVER, SUBSEQUENT ICM DEVICE DATA SHOWED NORMAL OPERATION WITH NO DEVICE FAULTS. BASED ON THE AVAILABLE INFORMATION, IT WAS DETERMINED THAT THE ICM LIKELY FUNCTIONED CORRECTLY AND THAT THE ISSUE WAS MORE LIKELY RELATED TO A TEMPORARY COMMUNICATION PROBLEM BETWEEN THE ICM AND LATITUDE MONITORING SYSTEM. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICM REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25774548 ↗
• InjuryJun 8, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT THIS INSERTABLE CARDIAC MONITOR (ICM) WAS HAVING CONNECTION ISSUES. IT WAS INDICATED THAT BATTERY COULD BE BEYOND END OF SERVICE (EOS) ACCORDING TO IMPLANT DATE. THE PATIENT WAS REFERRED TO THE CLINIC FOR DEVICE CHECK. THE ICM REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION REVEALED THAT THE PATIENT PRESENTED IN THE CLINIC, BUT THE ICM WAS UNABLE TO CONNECT. THE PATIENT WAS UPSET AND INSISTED ON HAVING IT REMOVED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25429730 ↗
• MalfunctionMay 29, 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 EXPLANTED AFTER BEING IMPLANTED AND IN-SERVICE FOR APPROXIMATELY 2 YEARS. THE DEVICE WAS RETURNED, AND DEVICE ANALYSIS WAS COMPLETED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25340668 ↗
• MalfunctionMay 29, 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 EXPLANTED AFTER BEING IMPLANTED AND IN-SERVICE FOR APPROXIMATELY 2 YEARS AND TWO MONTHS. THE DEVICE WAS RETURNED, AND DEVICE ANALYSIS WAS COMPLETED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25326511 ↗
• MalfunctionMay 28, 2026Premature Discharge of Battery; Communication or Transmission Problem

  IT WAS REPORTED THAT THIS INSERTABLE CARDIAC MONITOR (ICM) LAST TRANSMISSION WAS OVER 2 YEARS AGO. THE HEALTHCARE PROVIDER INDICATED THAT THEY THINK THAT THE BATTERY DEPLETED TWO YEARS AFTER INITIAL IMPLANT. THE HEALTHCARE PROVIDER WILL FOLLOW-UP WITH THE PATIENT TO CHECK IF THEY WANT THEIR ICM REPLACED. THE ICM REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25311811 ↗
• MalfunctionApr 27, 2026Incorrect, Inadequate or Imprecise Result or Readings; Communication or Transmission Problem

  IT WAS REPORTED THAT THIS INSERTABLE CARDIAC MONITOR (ICM) WAS DISABLE DUE TO POSSIBLE DEVICE MALFUNCTION. BOSTON SCIENTIFIC TECHNICAL SERVICES INDICATED THAT BASED ON THE DATE AND TIME BETWEEN THE LAST CONNECTION AND THE IMPLANT DATE, THE ICM PROBABLY HAD REACH THE END OF SERVICE (EOS) STATUS; HOWEVER, THE ALERT WAS A PARTIAL UPLOAD. THE HEALTHCARE PROVIDER CONFIRMED THAT PATIENT HAD MISSED LAST TWO SCHEDULE TRANSMISSION. THE ICM REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25001702 ↗
• MalfunctionMar 2, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE INSERTABLE CARDIAC MONITOR DEVICE WAS FLAGGED AS REACHING ITS END-OF-SERVICE STATUS EARLIER THAN EXPECTED, INDICATING IT DID NOT ACHIEVE ITS ANTICIPATED LONGEVITY PERIOD. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24492166 ↗
• MalfunctionFeb 18, 2026Incorrect, Inadequate or Imprecise Result or Readings; Communication or Transmission Problem

  IT WAS REPORTED THAT THE NEW PATIENT MOBILE MONITOR (PMM) WAS RECEIVED BY THE PATIENT, AND PAIRING WAS RELEASED AGAIN. THE MAGNET ATTACHMENT PROCESS WAS WALKED THROUGH, AND SETUP WAS ATTEMPTED BUT REMAINED INCOMPLETE, RESULTING IN DISABLED MONITORING DUE POSSIBLE DEVICE ISSUE. THE PATIENT RECEIVED EDUCATION ON THE INSERTABLE CARDIAC MONITOR BATTERY LIFE AND WAS REFERRED TO THE CLINIC FOR FURTHER EVALUATION. THE ICM REMAINS IN SERVICE, AND NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION REQUESTED ABOUT THE BATTERY LIFE, AND THE CASE WAS REFERRED TO THE CLINIC FOR FURTHER EVALUATION. HOWEVER, THE INFORMATION COULD NOT BE PROVIDED DUE TO UNAVAILABILITY FROM THE CUSTOMER/ACCOUNT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24381413 ↗
• InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS INSERTABLE CARDIAC MONITOR (ICM) HAD AN INFECTION. A REVISION WAS PERFORMED AND THE ICM WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 24313003 ↗
• InjuryDec 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 23931904 ↗
• MalfunctionDec 24, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS INSERTABLE CARDIAC MONITOR (ICM) DEPLETED PREMATURELY. THE ICM SHOWED A DECREASE IN BATTERY VOLTAGE THAT APPEARS TO BE FASTER THAN EXPECTED. IT WAS RECOMMENDED TO RETURN THE DEVICE FOR ANALYSIS. THE ICM REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23889517 ↗
• InjuryDec 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S INSERTABLE CARDIAC MONITOR (ICM) WAS REMOVED DUE TO PAIN AND DISCOMFORT AT THE IMPLANT SITE. THE CALLER ASKED ABOUT THE PROPER HANDLING OF THE PATIENT MOBILE MONITOR (PMM). TECHNICAL SERVICES ADVISED THAT THE PMM CAN BE DISPOSED OF AS A STANDARD HOUSEHOLD ELECTRONIC DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Discomfort; Implant Pain

  MAUDE report 23888078 ↗
• InjuryNov 28, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A HEALTH CARE PROFESSIONAL (HCP) IDENTIFIED A DEVICE MALFUNCTION. THE INSERTABLE CARDIAC MONITOR (ICM) WILL NO LONGER TRANSMIT DATA, AND THE ONLY CORRECTIVE ACTION IS EXPLANT AND REIMPLANT. THE HCP WAS ADVISED TO RETURN THE EXPLANTED DEVICE FOR ANALYSIS AND INFORMED THAT A LETTER OF ANALYSIS CAN BE REQUESTED IF NEEDED. THE HCP PLANS TO DISCUSS NEXT STEPS WITH THE PHYSICIAN. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICM REMAINS IN SERVICE. ADDITIONAL INFORMATION RECEIVED INDICATES THAT TECHNICAL SERVICES IDENTIFIED AN INTERNAL MALFUNCTION AND RECOMMENDED DEVICE REPLACEMENT. THE REPRESENTATIVE CONFIRMED THE CHANGE-OUT HAS ALREADY BEEN COMPLETED, LIKELY ON THE DAY OF THE INITIAL CALL, AND PATIENT RECORDS CAN VERIFY THIS. THE ORIGINAL ICM REMAINS WITH THE HOSPITAL AND WILL BE RETURNED AT THEIR DISCRETION. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23674023 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 23526296 ↗
• MalfunctionOct 20, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) CALLED BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) BECAUSE THIS INSERTABLE CARDIAC MONITOR (ICM) DEVICE HAD REACHED RECOMMENDED REPLACEMENT TIME (RRT) BATTERY STATUS EARLIER THAN EXPECTED AND HAD NOT MET THE PROJECTED LONGEVITY. THE HCP WONDERED IF IT COULD BE RELATED TO THE ICM DEVICE SETTINGS. TS MENTIONED SETTINGS WERE NOT SUSPECTED TO BE THE CAUSE OF THE REPORTED BATTERY CONDITION AND REQUESTED ENGINEERING TO ANALYZE THE ICM DEVICE DATA. IN ADDITION, TS DISCUSSED THIS PATIENT WAS NO LONGER BEING MONITORED DUE TO THE REPORTED ISSUE. ANALYSIS OF ICM DEVICE DATA INDICATES THE BATTERY VOLTAGE DROPPED RAPIDLY A FEW MONTHS BEFORE THE RRT BATTERY STATUS OCCURRED. THE ROOT CAUSE IS UNKNOWN; HENCE, THE ICM DEVICE SHOULD BE RETURNED FOR A DETAILED ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICM DEVICE REMAINS IMPLANTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23341480 ↗
• InjuryOct 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH A HISTORY OF CEREBROVASCULAR ACCIDENT PRESENTED WITH DISCOMFORT RELATED TO AN INSERTABLE CARDIAC MONITOR (ICM). DUE TO ONGOING SYMPTOMS, THE PATIENT REQUESTED DEVICE REMOVAL AND REQUESTED ICM REMOVAL. ADDITIONALLY, THE ICM HAD REACHED EFFECTIVE REPLACEMENT STATUS APPROXIMATELY THREE YEARS AND SIX MONTHS AFTER IMPLANTATION. BATTERY DEPLETION WAS CONSISTENT WITH THE EXPECTED SERVICE LIFE, CONFIRMING NORMAL DEVICE USAGE. THE ICM WAS EXPLANTED AND RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE EFFECTS WERE REPORTED FOR THE PATIENT.

  Patient problems: Discomfort

  MAUDE report 23222446 ↗
• MalfunctionSep 11, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE INSERTABLE CARDIAC MONITOR (ICM) WAS ATTEMPTED TO BE IMPLANTED BUT A MESSAGE FOR LOW BATTERY CONDITION APPEARED. NO OTHER DEVICE WAS USED AS THE PATIENT HAD A STROKE AND WAS NOT ABLE TO KEEP HIS ARMS STILL. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23033504 ↗
• MalfunctionSep 11, 2025Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE INSERTABLE CARDIAC MONITOR (ICM) SHOWED AN ERROR MESSAGE "IMPLANT IS NOT RECOMMENDED". THE REP WAS INFORMED NOT TO IMPLANT AND TO RETURN THE DEVICE FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23033502 ↗
• MalfunctionSep 11, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE INSERTABLE CARDIAC MONITOR (ICM) SHOWED A "DO NOT IMPLANT DUE TO LOW BATTERY" ERROR MESSAGE. THE REP SET ASIDE AND DID NOT USE THE DEVICE. THE REP FOLLOWED THE PROTOCOL TO WAIT 24 HOURS AND REINTERROGATE THE DEVICE. THE REP NOTED THE ICM WAS ALREADY ENROLLED TO THE PATIENT AND NEEDED TECHNICAL SERVICES (TS) TO HELP UNDO THAT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23033494 ↗