Jot Dx™ DM4500Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,005 adverse event reports that list this exact device (DI 05415067040046), received between Oct 6, 2021 and Sep 29, 2026 — classified as 1 death, 158 injuries, 846 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (438 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 1,005 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Insufficient Device Problem Information

  It was reported that the patient¿s insertable cardiac monitor (ICM) was no longer functioning. The ICM was explanted. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927331 ↗
• MalfunctionSep 24, 2026Signal Artifact/Noise; Incorrect, Inadequate or Imprecise Result or Readings; Under-Sensing

  It was reported that the patient presented remotely via Merlin.net. Upon review of the transmission, the implantable cardiac monitor (ICM) was noted to exhibit undersensing, noise, and marker anomaly. No intervention was performed. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50878377 ↗
• MalfunctionSep 11, 2026Signal Artifact/Noise

  It was reported that the patient presented remotely via Merlin.net. Review of the transmission revealed that the implantable cardiac monitor (ICM) exhibited signal artifact following a ventricular ectopic. No intervention or changes were performed. No patient consequences were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50727428 ↗
• InjurySep 1, 2026Premature Discharge of Battery

  It was reported that the patient experienced discomfort due to the Insertable Cardiac Monitor (ICM). Additionally, the Insertable Cardiac Monitor (ICM) battery was depleted. The physician explanted the ICM. There were no patient complications reported.

  Patient problems: Discomfort

  MAUDE report 50547380 ↗
• MalfunctionAug 21, 2026Failure to Interrogate

  It was reported that a patient presented to clinic for follow up. Their Insertable Cardiac Monitor (ICM) was unable to be interrogated despite multiple attempts. No changes or interventions were performed. The patient condition was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50373200 ↗
• MalfunctionAug 18, 2026Signal Artifact/Noise

  It was reported that, noise was observed on the device. Additional information was requested but has not been provided. The patient was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50299427 ↗
• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented to the clinic with pain at the implanted device pocket site. The implantable cardiac monitor was explanted. No additional adverse patient effects were reported.

  Patient problems: Discomfort

  MAUDE report 50065824 ↗
• MalfunctionJun 30, 2026Failure to Interrogate; Incorrect Measurement

  IT WAS REPORTED THAT DURING A REMOTE FOLLOW-UP, THE DEVICE WAS UNABLE TO CONNECT TO THE MOBILE TRANSMITTER VIA BLUETOOTH TELEMETRY. THE PATIENT WAS SEEN IN CLINIC, AND A MAGNET WAS APPLIED TO REACTIVATE THE BLUETOOTH. ADDITIONALLY, THE IMPLANT DATE WAS REPROGRAMMED INTO THE DEVICE AS IT WAS MISSING. THERE WAS A TRANSMISSION IN MERLIN.NET THAT SHOWED THE DEVICE HAD VERY LITTLE BATTERY LEFT. HOWEVER, FOLLOWING INTERROGATION, THE BATTERY WAS NEARLY FULL. THE PATIENT WAS IN STABLE CONDITION AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25668890 ↗
• MalfunctionJun 29, 2026Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A DEVICE CHECK. DEVICE INTERROGATION INDICATED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) EXHIBITED ELECTROMAGNETIC INTERFERENCE (EMI) OVERSENSING. NO CHANGES OR INTERVENTION WERE REPORTED. THE PATIENT CONDITION WAS NOT KNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25648795 ↗
• MalfunctionJun 11, 2026Premature Discharge of Battery; Wireless Communication Problem

  IT WAS REPORTED DURING REMOTE FOLLOW UP THAT THE INSERTABLE CARDIAC MONITOR (ICM) EXHIBITED AN INABILITY TO PAIR. POTENTIAL PREMATURE BATTERY DEPLETION WAS NOTED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25472829 ↗
• MalfunctionMay 22, 2026Failure to Interrogate

  DURING AN IN CLINIC FOLLOW-UP, THE DEVICE WAS INTERROGATED AND WAS UNABLE TO COMMUNICATE VIA BLUETOOTH TELEMETRY. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25260058 ↗
• MalfunctionMay 11, 2026Failure to Interrogate

  IT WAS REPORTED THAT THE PATIENT'S INSERTABLE CARDIAC MONITOR (ICM) EXHIBITED LOSS OF BLUETOOTH TELEMETRY. NO INTERVENTION WAS PERFORMED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25137693 ↗
• MalfunctionMay 8, 2026Failure to Interrogate

  IT WAS REPORTED THAT THE INSERTABLE CARDIAC MONITOR EXHIBITED FAILURE TO INTERROGATION VIA BLUETOOTH TELEMETRY. NO INTERVENTION WAS PERFORMED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25130417 ↗
• MalfunctionMay 5, 2026Under-Sensing

  IT WAS REPORTED THAT UNDERSENSING WAS OBSERVED ON THE DEVICE. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED. THERE WERE NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25082858 ↗
• MalfunctionMay 3, 2026Premature Discharge of Battery; Failure to Interrogate

  IT WAS REPORTED THAT DURING A FOLLOW UP IN CLINIC, THE DEVICE WAS UNABLE TO BE INTERROGATED. THE PHYSICIAN SUSPECTED PREMATURE BATTERY DEPLETION. NO INTERVENTION HAS BEEN PERFORMED AT THIS TIME. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25063782 ↗
• MalfunctionApr 30, 2026Failure to Interrogate

  IT WAS REPORTED THAT THE PATIENT'S INSERTABLE CARDIAC MONITOR (ICM) EXHIBITED LOSS OF BLUETOOTH TELEMETRY. NO INTERVENTION WAS PERFORMED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25049195 ↗
• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED AT THE HOSPITAL WITH SKIN DISCOMFORT. THE IMPLANTABLE CARDIAC MONITOR WAS EXPLANTED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: Discomfort

  MAUDE report 25039475 ↗
• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELT DISCOMFORT WITH THE IMPLANTABLE CARDIAC MONITOR (ICM). THE ICM WAS EXPLANTED. THE PATIENT HAD NO CONSEQUENCES.

  Patient problems: Discomfort

  MAUDE report 25012674 ↗
• MalfunctionApr 23, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE INSERTABLE CARDIAC MONITOR (ICM) EXHIBITED PREMATURE BATTERY DEPLETION. NO INTERVENTION WAS REPORTED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24968088 ↗
• MalfunctionApr 22, 2026Premature Discharge of Battery

  NEW INFORMATION RECEIVED NOTES THAT NO PHYSICIAN WAS INVOLVED AND NO PATIENT CONSEQUENCES WERE NOTED. DEVICE WAS NEITHER IMPLANTED NOR REMOVED FROM ITS INNER STERILE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24958790 ↗
• MalfunctionApr 21, 2026Under-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF THE TRANSMISSION REVEALED THAT THE LOOP RECORDER EXHIBITED UNDERSENSING. FURTHER INFORMATION WAS REQUESTED; HOWEVER, WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24941475 ↗
• MalfunctionApr 17, 2026Under-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY TO THE CLINIC VIA MERLIN.NET TRANSMISSION. REVIEW OF THE TRANSMISSION INDICATED THAT THE PATIENT¿S INSERTABLE CARDIAC MONITOR (ICM) RECORDED FALSE PAUSE EPISODES, ATTRIBUTED TO UNDER-SENSING CAUSED BY LOSS OF TISSUE CONTACT, POSSIBLY RELATED TO LOCAL MANIPULATION OF THE DEVICE AREA. PROGRAMMING CHANGES WERE DISCUSSED BUT NOT MADE. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24906763 ↗
• MalfunctionApr 16, 2026Over-Sensing

  DURING A CLINIC FOLLOW-UP, EPISODES OF POST-SENSED T WAVE OVERSENSING WERE OBSERVED ON THE DEVICE. TECHNICAL SUPPORT WAS CONTACTED, BUT NO INTERVENTION HAS BEEN PERFORMED AT THIS TIME. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24899839 ↗
• MalfunctionApr 11, 2026Under-Sensing

  IT WAS REPORTED THAT UNDERSENSING WAS OBSERVED ON THE DEVICE. ABBOTT TECHNICAL SUPPORT WAS CONTACTED AND RECOMMENDED REPROGRAMMING, WHICH WAS ANTICIPATED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND THERE WERE NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24848821 ↗
• MalfunctionApr 5, 2026Under-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. IT WAS NOTED THAT THE IMPLANTABLE CARDIAC MONITOR EXHIBITED UNDER-SENSING. NO INTERVENTION WAS PERFORMED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24787087 ↗