LUX-Dx II+Recalls & reported problems across all models

We found 2 models of LUX-Dx II+ by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 506 adverse event reports in the FDA's MAUDE database, received between Jul 15, 2024 and Sep 28, 2026 — classified as 272 injuries, 234 malfunctions.

The most frequently reported specific device problem is “Data Problem” (155 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

LUX-Dx II+ recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Mar 30, 2026Open, 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 ↗

2. Mar 30, 2026Open, 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 LUX-Dx II+ problems

LUX-Dx II+ models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• LUX-Dx II+™ 60M312-100

  Recorder, event, implantable cardiac, (with arrhythmia detection)
  1 recall429 reports
• LUX-Dx II™ 60M302-100

  Recorder, event, implantable cardiac, (with arrhythmia detection)
  1 recall77 reports

Recent LUX-Dx II+ adverse event reports

The 15 most recent reports across all models, 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, 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 25, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50892559 ↗
• 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 ↗

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