LUX-Dx II+™ 60M312-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 429 adverse event reports that list this exact device (DI 00802526620706), received between Jul 15, 2024 and Sep 25, 2026 — classified as 219 injuries, 210 malfunctions.

The most frequently reported specific device problem is “Data Problem” (152 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-2049-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 429 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that this insertable cardiac monitor (ICM) got a low battery alert pre-implant. The ICM was not implanted and segregated. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903644 ↗
• MalfunctionSep 25, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50892563 ↗
• MalfunctionSep 24, 2026Signal Artifact/Noise; False Negative Result; False Positive Result; Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50890393 ↗
• InjurySep 24, 2026Premature Discharge of Battery

  It was reported that this Insertable Cardiac Monitor (ICM) was explanted for battery replacement. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889972 ↗
• MalfunctionSep 24, 2026Premature Discharge of Battery

  It was reported that this Insertable Cardiac Monitor (ICM) device was interrogated and showed End of Service. Technical Services recommended device replacement and requested the device be returned for analysis. Additional information indicated that the patient had been wearing a magnet over the implant area since the time of implant. The potential effects were discussed; patient education and physician notification were recommended. No adverse patient effects were reported. This ICM remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885288 ↗
• MalfunctionSep 22, 2026Premature Discharge of Battery

  It was reported that this Insertable Cardiac Monitor reached the Recommended Replacement Time earlier than expected. Engineering analysis found evidence of excessive magnet use, which increased power consumption and most likely caused premature battery depletion. The findings were communicated to the field representative. No adverse patient effects were reported. This product remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50856105 ↗
• MalfunctionSep 11, 2026Premature Discharge of Battery

  It was reported that an Insertable Cardiac Monitor (ICM) indicated an EOS (End of Service) condition during preparation for implant. The Insertable Cardiac Monitor had been enrolled but was not implanted, and an alternate Insertable Cardiac Monitor was used instead. Technical Services requested return of the affected Insertable Cardiac Monitor for evaluation; however, the hospital retained and subsequently discarded the Insertable Cardiac Monitor, making product analysis unavailable. The representative later confirmed that the Insertable Cardiac Monitor successfully transmitted a remote report prior to disposal. No patient impact occurred because the Insertable Cardiac Monitor was not implanted. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50733404 ↗
• MalfunctionSep 11, 2026Premature Discharge of Battery

  It was reported that the Insertable Cardiac Monitor (ICM) experienced a sudden drop in battery voltage resulting in an end of service condition. Technical assessment determined that the battery voltage decline occurred unexpectedly and the cause of the depletion is unknown. No patient impact was reported. The ICM remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50733078 ↗
• MalfunctionSep 9, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50699816 ↗
• InjurySep 4, 2026Failure to Read Input Signal; Device Sensing Problem

  It was reported that this newly implanted Insertable Cardiac Monitor (ICM) device initially functioned as expected. After the procedure was completed and the incision was closed the transmitted signal became indiscernible despite confirmation of proper ICM device placement via X-Ray. Troubleshooting efforts did not restore adequate sensing; therefore, the ICM was explanted and replaced. The new ICM showed normal signal quality, and the explanted ICM was returned for analysis. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602245 ↗
• MalfunctionSep 4, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602236 ↗
• MalfunctionSep 4, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that this insertable cardiac monitor (ICM) trigger and alert that indicated "ICM insertion not recommended due to low battery condition, prior to implant. Boston Scientific Technical Services indicated to not implant the ICM and return it. No adverse patient effects were reported.Additional information indicated that there was no particular patient attach to this ICM. The representative was checking on the statues of multiple ICMs when this ICM was found to present this alert. No patient Involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602173 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a connection check was performed, but no response was received from the Insertable Cardiac Monitor (ICM). The Health Care Professional (HCP) was unable to feel the device, although the incision site was visible. The issue remained unresolved. A possible device erosion was suspected, and a chest X-ray was recommended to confirm the ICM location. Additional information received from the field representative indicates that no infection was noted in the patient, and no further action has been taken at this time. No additional adverse patient effects were reported. This ICM remains in service.

  Patient problems: Pocket Erosion

  MAUDE report 50602106 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this insertable cardiac monitor (ICM) was sticking out of the incision. The ICM was removed. The product returned was requested. No new ICM was implanted. No adverse patient effects were reported.Additional information indicated that the ICM will not be returned to BSC as it was discarded by the clinic. No adverse patient effects were reported.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 50602078 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Insertable Cardiac Monitor (ICM) was explanted due to infection, as required. No additional adverse patient effects were reported.

  Patient problems: Unspecified Infection

  MAUDE report 50600346 ↗
• InjuryAug 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Insertable Cardiac Monitor (ICM) was explanted due to infection. No additional adverse patient effects were reported.

  Patient problems: Unspecified Infection

  MAUDE report 50509994 ↗
• MalfunctionAug 17, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50280344 ↗
• MalfunctionAug 17, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50280338 ↗
• MalfunctionAug 14, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50256090 ↗
• InjuryAug 14, 2026Communication or Transmission Problem

  It was reported that this patient application was not connecting. The patient was using the application. There was no response from the insertable cardiac monitor (ICM). The patient application software was uninstalled and reinstalled. The ICM was not responding to magnet swipe. The patient indicated that they could feel the ICM. The patient was referred to the clinic for a device check. The ICM remains in service and no adverse patient effects.Additional information indicated that ICM was not responding to magnet swipe. They tried to used a donut magnet but there wasn't a response. The representative indicated that they can feel the ICM. It was advised that replacement might be needed, and to send the device back for analysis. The ICM remains in service and no adverse patient effects were reported.Additional information indicated that this ICM was explanted. The ICM has been returned to BSC. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50256085 ↗
• MalfunctionAug 14, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50256069 ↗
• MalfunctionAug 14, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50256056 ↗
• MalfunctionAug 14, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50256050 ↗
• MalfunctionAug 14, 2026False Negative Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50256048 ↗
• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient with this insertable cardiac monitor (ICM) noticed that there was white liquid in the incision area like pus. The patient was referred to the clinic. The ICM remains in service and no adverse patient effects were reported.The ICM was explanted due to infection. It was indicated that the incision area was contaminated with MRSA. No new device was implanted. The original ICM will not be returned. No additional adverse patient effects were reported.

  Patient problems: Bacterial Infection; Fluid Discharge

  MAUDE report 50255921 ↗