AfibAlert / hom ecg+ V2.0Recalls & reported problems
Lohman Technologies, LLC · The hom ecg+ / AfibAlert® is a cardiac event recorder capable of recording and storing approximately thirty 45-second events in solid-state non-volatile memory. The hom ecg+ / AfibAlert® allows patients who have been diagnosed with, or are susceptible to developing atrial fibrillation (AF) to take periodic readings with a computerized rhythm monitor. The system was developed for the patient that is at risk or has been previously diagnosed with AF, has a history of heart bypass, ablation, or other cardiac abnormality, or is on heart (anti-arrhythmic) medication. In these cases, detecting and determining AF early can potentially reduce the risk of heart attack and stroke. The device can record a single channel of ECG data in three ways: (I) via the two thumb electrodes, (2) by applying wrist electrodes or (3) applying two sticky electrodes as instructed by their health care practitioner. In each case, the patient initiates the recording. An individual recording will take ~45 seconds. Immediately following data acquisition, an internal AF algorithm is used to analyze the patient's rhythm. The built-in graphical LCD display indicates the presence or absence of AF. If ECG data is present (whether or not AF is indicated) the device uses an internal cellular module to transfer the ECG data to the cloud to be viewed and/or shared with their physician or health care practitioner using either company developed or third party developed internet based software program(s). · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 18
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00860003939734), received between Aug 22, 2025 and Dec 12, 2025 — classified as 18 malfunctions.
The most frequently reported specific device problem is “Power Problem” (7 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.
Reports received per month
Most reported problems
Device problems
- Power Problem7
- Connection Problem3
- Failure to Power Up3
- Application Program Problem2
- Electrical /Electronic Property Problem2
- Communication or Transmission Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions18
Recent adverse event reports
The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 12, 2025Connection Problem; Connection Problem
THE PATIENT REPORTS THAT THE DEVICE SHUTS OFF BEFORE A READING IS TAKEN. THE PATIENT HAD NO ADVERSE EVENT OR REACTION RESULTING FROM THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23791439 ↗MalfunctionDec 12, 2025Power Problem; Power Problem
THE PATIENT REPORTS THAT THE DEVICE TURNS ON AND TURNS OFF AFTER A FEW SECONDS DESPITE CHANGING BATTERIES. THE PATIENT HAD NO ADVERSE EVENT OR REACTION RESULTING FROM THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23791391 ↗MalfunctionDec 12, 2025Communication or Transmission Problem; Communication or Transmission Problem
THE PATIENT REPORTS THAT THE DEVICE BLINKS A BLANK SCREEN DESPITE CHANGING BATTERIES. THE PATIENT HAD NO ADVERSE EVENT OR REACTION RESULTING FROM THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23791389 ↗MalfunctionDec 12, 2025Connection Problem; Connection Problem
THE PATIENT REPORTS THAT THE DEVICE TURNS ON AND TURNS OFF DESPITE CHANGING BATTERIES. THE PATIENT HAD NO ADVERSE EVENT OR REACTION RESULTING FROM THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23791388 ↗MalfunctionDec 12, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THE PATIENT REPORTS THAT THE DEVICE POWERS ON, THEN TURNS OFF AFTER A FEW SECONDS AND DOES NOT GO INTO THE FULL COUNTDOWN. THE PATIENT HAD NO ADVERSE EVENT OR REACTION RESULTING FROM THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23791368 ↗MalfunctionDec 12, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THE PATIENT REPORTS THAT THE DEVICE SHUTS OFF AFTER BEING TURNED ON AND DOES NOT COMPLETE THE FULL COUNTDOWN. THE PATIENT HAS REPLACED THE BATTERIES BUT THE ISSUE PERSISTS. THE PATIENT HAD NO ADVERSE EVENT OR REACTION RESULTING FROM THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23791345 ↗MalfunctionOct 30, 2025Connection Problem; Connection Problem
DEVICE DOES NOT COUNTDOWN. THE PATIENT HAD NO ADVERSE EVENT OR REACTION RESULTING FROM THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23432868 ↗MalfunctionSep 12, 2025Power Problem; Power Problem
THE PATIENT REPORTS THAT THE DEVICE TURNS ON AND TURNS OFF AFTER A FEW SECONDS DESPITE CHANGING BATTERIES. THE PATIENT HAD NO ADVERSE EVENT OR REACTION FROM THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23043095 ↗MalfunctionAug 22, 2025Power Problem; Power Problem
THE PATIENT REPORTS THAT THE DEVICE POWERS DOWN DESPITE MULTIPLE BATTERY CHANGES. THE PATIENT HAD NO ADVERSE EVENT OR A REACTION RESULTING FROM THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22874414 ↗MalfunctionAug 22, 2025Power Problem; Power Problem
THE PATIENT REPORTS THAT THE DEVICE TURNS ON AND READS "FACTORY RESET" THEN SHUTS BACK OFF AFTER CHANGING BATTERIES. THE PATIENT HAD NO ADVERSE EVENT OR A REACTION RESULTING FROM THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22874400 ↗MalfunctionAug 22, 2025Power Problem; Power Problem
THE PATIENT REPORTS THAT THE DEVICE CONTINUES TO POWER OFF DESPITE MULTIPLE BATTERY CHANGES. THE PATIENT HAD NO ADVERSE EVENT OR A REACTION RESULTING FROM THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22874398 ↗MalfunctionAug 22, 2025Power Problem; Power Problem
THE PATIENT REPORTS THAT THE DEVICE POWERS DOWN DESPITE MULTIPLE BATTERY CHANGES. THE PATIENT HAD NO ADVERSE EVENT OR A REACTION RESULTING FROM THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22874366 ↗MalfunctionAug 22, 2025Failure to Power Up; Failure to Power Up
THE PATIENT REPORTS THAT THE DEVICE DOES NOT TURN ON, EVEN DESPITE MULTIPLE BATTERY CHANGES. THE PATIENT HAD NO ADVERSE EVENT OR A REACTION RESULTING FROM THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22874313 ↗MalfunctionAug 22, 2025Failure to Power Up; Failure to Power Up
THE PATIENT REPORTS THAT THE DEVICE DOES NOT TURN ON, EVEN DESPITE MULTIPLE BATTERY CHANGES. THE PATIENT HAD NO ADVERSE EVENT OR A REACTION RESULTING FROM THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22874289 ↗MalfunctionAug 22, 2025Failure to Power Up; Failure to Power Up
THE PATIENT REPORTS THAT THE DEVICE DOES NOT TURN ON, EVEN DESPITE A BATTERY CHANGE. THE PATIENT HAD NO ADVERSE EVENT OR A REACTION RESULTING FROM THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22874252 ↗MalfunctionAug 22, 2025Power Problem; Power Problem
THE PATIENT REPORTS RECEIVING A NEW DEVICE THAT POWERS ON AND THEN INDICATES THAT THERE IS LOST CONTACT AND POWERS OFF. THE PATIENT HAD NO ADVERSE EVENT OR REACTION RESULTING FROM THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22874250 ↗MalfunctionAug 22, 2025Application Program Problem; Application Program Problem
THE PATIENT REPORTS COLLECTING STEADY READINGS SINCE RECEIVING THE DEVICE BUT HAS STARTED EXPERIENCING ISSUES WITH GETTING A READING. THE PATIENT HAD NO ADVERSE EVENT OR A REACTION RESULTING FROM THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22874184 ↗MalfunctionAug 22, 2025Application Program Problem; Application Program Problem
THE PATIENT REPORTS RECEIVING AN UNABLE TO ANALYZE RESULT THE MAJORITY OF THE TIME WHEN ATTEMPTING READINGS. WHEN REVIEWING DATA UPLOADED TO THE CLOUD, THERE ARE INCONSISTENCIES IN THE DATA AVAILABLE. THE PATIENT HAD NO ADVERSE EVENT OR A REACTION RESULTING FROM THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22873951 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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