Zio ECG Utilization Software (ZEUS) System FG0401USRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00850043907046), received between Dec 14, 2023 and Aug 20, 2024 — classified as 3 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Inaccurate Information” (17 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 16, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryAug 20, 2024Adverse Event Without Identified Device or Use Problem; Inaccurate Information; Adverse Event Without Identified Device or Use Problem; Inaccurate Information

  THE PATIENT EXPERIENCED AN ARRHYTHMIA THAT MET MEDICAL DOCTOR NOTIFICATION (MDN) REQUIREMENTS THAT WAS NOT COMMUNICATED DURING THE WEAR PERIOD. THE INVESTIGATION REVEALED THAT A PRELIMINARY ECG INTERPRETATION PROVIDED TO THE PHYSICIAN WAS MISCLASSIFIED. FOLLOWING THE WEAR PERIOD AND WHILE COMPILING THE FINAL REPORT, THE INTERPRETATION WAS AMENDED. THE HCP WAS NOTIFIED IMMEDIATELY, AND IRHYTHM LEARNED THAT THE PATIENT RECEIVED A PACEMAKER DUE TO THE INITIAL FALSE POSITIVE INTERPRETATION. IT IS UNKNOWN WHETHER THE PACEMAKER WILL BE REMOVED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 20006481 ↗
• InjuryJul 18, 2024Inaccurate Information; Inaccurate Information

  THE PATIENT EXPERIENCED AN ARRHYTHMIA THAT MET MEDICAL DOCTOR NOTIFICATION (MDN) REQUIREMENTS THAT WAS NOT COMMUNICATED DURING THE WEAR PERIOD. THE INVESTIGATION REVEALED THAT A PRELIMINARY ECG INTERPRETATION PROVIDED TO THE PHYSICIAN WAS MISCLASSIFIED. FOLLOWING THE WEAR PERIOD AND WHILE COMPILING THE FINAL REPORT, THE INTERPRETATION WAS AMENDED. THE HCP WAS NOTIFIED IMMEDIATELY, AND IRHYTHM LEARNED THAT THE PATIENT RECEIVED A PACEMAKER DUE TO THE INITIAL INTERPRETATION.

  Patient problems: Unspecified Heart Problem

  MAUDE report 19778852 ↗
• MalfunctionJun 27, 2024Inaccurate Information; Inaccurate Information

  THE PATIENT EXPERIENCED AN ARRHYTHMIA THAT MET MEDICAL DOCTOR NOTIFICATION (MDN) REQUIREMENTS THAT WAS NOT COMMUNICATED DURING THE WEAR PERIOD. THE INVESTIGATION REVEALED THAT A PRELIMINARY ECG INTERPRETATION PROVIDED TO THE PHYSICIAN WAS MISCLASSIFIED. FOLLOWING THE WEAR PERIOD AND WHILE COMPILING THE FINAL REPORT, THE INTERPRETATION WAS AMENDED. THE HCP WAS NOTIFIED IMMEDIATELY, AND IRHYTHM LEARNED THAT THE HCP WAS ALREADY AWARE OF THE PATIENT'S ARRHYTHMIA. NO ADVERSE EVENTS, SUCH AS DEATH OR SERIOUS INJURY, ARE KNOWN TO HAVE OCCURRED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 19628844 ↗
• MalfunctionJun 18, 2024Inaccurate Information; Inaccurate Information

  THE PATIENT EXPERIENCED AN ARRHYTHMIA THAT MET MEDICAL DOCTOR NOTIFICATION (MDN) REQUIREMENTS THAT WAS NOT COMMUNICATED DURING THE WEAR PERIOD. THE INVESTIGATION REVEALED THAT A PRELIMINARY ECG INTERPRETATION PROVIDED TO THE PHYSICIAN WAS MISCLASSIFIED. FOLLOWING THE WEAR PERIOD AND WHILE COMPILING THE FINAL REPORT, THE INTERPRETATION WAS AMENDED. THE HCP WAS NOTIFIED IMMEDIATELY, AND IRHYTHM LEARNED THAT THE HCP WAS ALREADY AWARE OF THE PATIENT'S ARRHYTHMIA. NO ADVERSE EVENTS, SUCH AS DEATH OR SERIOUS INJURY, ARE KNOWN TO HAVE OCCURRED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 19563910 ↗
• MalfunctionMay 8, 2024Inaccurate Information; Inaccurate Information

  THE PATIENT EXPERIENCED AN ARRHYTHMIA THAT MET MEDICAL DOCTOR NOTIFICATION (MDN) REQUIREMENTS THAT WAS NOT COMMUNICATED DURING THE WEAR PERIOD. THE INVESTIGATION REVEALED THAT A PRELIMINARY ECG INTERPRETATION PROVIDED TO THE PHYSICIAN WAS MISCLASSIFIED. FOLLOWING THE WEAR PERIOD AND WHILE COMPILING THE FINAL REPORT, THE INTERPRETATION WAS AMENDED. THE HCP WAS NOTIFIED IMMEDIATELY, AND IRHYTHM LEARNED THAT THE HCP WAS ALREADY AWARE OF THE PATIENT'S ARRHYTHMIA. NO ADVERSE EVENTS, SUCH AS DEATH OR SERIOUS INJURY, ARE KNOWN TO HAVE OCCURRED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 19271064 ↗
• MalfunctionApr 19, 2024Inaccurate Information; Inaccurate Information

  THE PATIENT EXPERIENCED AN ARRHYTHMIA THAT MET MEDICAL DOCTOR NOTIFICATION (MDN) REQUIREMENTS THAT WAS NOT COMMUNICATED DURING THE WEAR PERIOD. THE INVESTIGATION REVEALED THAT A PRELIMINARY ECG INTERPRETATION PROVIDED TO THE PHYSICIAN WAS MISCLASSIFIED. FOLLOWING THE WEAR PERIOD AND WHILE COMPILING THE FINAL REPORT, THE INTERPRETATION WAS AMENDED. THE HCP WAS NOTIFIED IMMEDIATELY, AND IRHYTHM LEARNED THAT THE HCP WAS ALREADY AWARE OF THE PATIENT'S ARRHYTHMIA AND WAS TREATING IT. THERE WERE NO DELAYS IN TREATMENT, AND NO ADVERSE EVENTS, SUCH AS DEATH OR SERIOUS INJURY, ARE KNOWN TO HAVE OCCURRED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 19145790 ↗
• MalfunctionApr 10, 2024Failure to Transmit Record; Failure to Transmit Record

  THE PATIENT EXPERIENCED AN ARRHYTHMIA THAT MET MEDICAL DOCTOR NOTIFICATION (MDN) REQUIREMENTS THAT WAS NOT COMMUNICATED DURING THE WEAR PERIOD. THE INVESTIGATION REVEALED THAT A PRELIMINARY ECG INTERPRETATION PROVIDED TO THE PHYSICIAN WAS MISCLASSIFIED. FOLLOWING THE WEAR PERIOD AND WHILE COMPILING THE FINAL REPORT, THE INTERPRETATION WAS AMENDED. THE HEALTHCARE PROVIDER (HCP) WAS IMMEDIATELY NOTIFIED, AND IRHYTHM LEARNED THAT THE HCP WAS ALREADY AWARE OF THE PATIENT'S ARRHYTHMIA AND WAS TREATING IT. THERE WERE NO DELAYS IN TREATMENT, AND NO ADVERSE EVENTS, SUCH AS DEATH OR SERIOUS INJURY, ARE KNOWN TO HAVE OCCURRED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 19085481 ↗
• MalfunctionApr 5, 2024Inaccurate Information; Inaccurate Information

  THE PATIENT EXPERIENCED AN ARRHYTHMIA THAT MET MEDICAL DOCTOR NOTIFICATION (MDN) REQUIREMENTS THAT WAS NOT COMMUNICATED DURING THE WEAR PERIOD. THE INVESTIGATION REVEALED THAT A PRELIMINARY ECG INTERPRETATION PROVIDED TO THE PHYSICIAN WAS MISCLASSIFIED. FOLLOWING THE WEAR PERIOD AND WHILE COMPILING THE FINAL REPORT, THE INTERPRETATION WAS AMENDED. THE HCP WAS NOTIFIED IMMEDIATELY, AND IRHYTHM LEARNED THAT THE HCP WAS ALREADY AWARE OF THE PATIENT'S ARRHYTHMIA AND OPTED NOT TO TREAT FOR THE ARRYTHMIA DUE TO THE HISTORY OF IT. THERE WERE NO DELAYS IN TREATMENT, AND NO ADVERSE EVENTS, SUCH AS DEATH OR SERIOUS INJURY, ARE KNOWN TO HAVE OCCURRED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 19051909 ↗
• InjuryMar 23, 2024Inaccurate Information; Inaccurate Information

  THE PATIENT EXPERIENCED AN ARRHYTHMIA THAT MET MEDICAL DOCTOR NOTIFICATION (MDN) REQUIREMENTS THAT WAS NOT COMMUNICATED DURING THE WEAR PERIOD. THE INVESTIGATION REVEALED THAT A PRELIMINARY ECG INTERPRETATION PROVIDED TO THE PHYSICIAN WAS MISCLASSIFIED. FOLLOWING THE WEAR PERIOD AND WHILE COMPILING THE FINAL REPORT, THE INTERPRETATION WAS AMENDED. THE HEALTHCARE PROVIDER (HCP) WAS IMMEDIATELY NOTIFIED, AND IRHYTHM LEARNED THAT THE PATIENT HAD RECEIVED A PACEMAKER DUE TO THE INITIAL INTERPRETATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 18965348 ↗
• MalfunctionMar 23, 2024Inaccurate Information; Inaccurate Information

  THE PATIENT EXPERIENCED AN ARRHYTHMIA THAT MET MEDICAL DOCTOR NOTIFICATION (MDN) REQUIREMENTS THAT WAS NOT COMMUNICATED DURING THE WEAR PERIOD. THE INVESTIGATION REVEALED THAT A PRELIMINARY ECG INTERPRETATION PROVIDED TO THE PHYSICIAN WAS MISCLASSIFIED. FOLLOWING THE WEAR PERIOD AND WHILE COMPILING THE FINAL REPORT, THE INTERPRETATION WAS AMENDED. THE HEALTHCARE PROVIDER (HCP) WAS IMMEDIATELY NOTIFIED, BUT IT WAS UNCLEAR WHETHER THE PATIENT WOULD RECEIVE TREATMENT. DESPITE SEVERAL ATTEMPTS TO GATHER MORE INFORMATION, NO ADDITIONAL DETAILS WERE OBTAINED. NO ADVERSE EVENTS, SUCH AS DEATH OR SERIOUS INJURY, ARE KNOWN TO HAVE OCCURRED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 18965339 ↗
• MalfunctionMar 12, 2024Inaccurate Information; Inaccurate Information

  THE PATIENT EXPERIENCED AN ARRHYTHMIA THAT MET MEDICAL DOCTOR NOTIFICATION (MDN) REQUIREMENTS THAT WAS NOT COMMUNICATED DURING THE WEAR PERIOD. THE INVESTIGATION REVEALED THAT A PRELIMINARY ECG INTERPRETATION PROVIDED TO THE PHYSICIAN WAS MISCLASSIFIED. FOLLOWING THE WEAR PERIOD AND WHILE COMPILING THE FINAL REPORT, THE INTERPRETATION WAS AMENDED. THE HCP WAS NOTIFIED IMMEDIATELY, AND IRHYTHM LEARNED THAT THE PATIENT¿S CARE TEAM IS CONSIDERING THE TREATMENT OPTIONS. NO ADVERSE EVENTS, SUCH AS DEATH OR SERIOUS INJURY, ARE KNOWN TO HAVE OCCURRED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 18888056 ↗
• MalfunctionMar 7, 2024Inaccurate Information; Inaccurate Information

  THE PATIENT EXPERIENCED AN ARRHYTHMIA THAT MET MEDICAL DOCTOR NOTIFICATION (MDN) REQUIREMENTS THAT WAS NOT COMMUNICATED DURING THE WEAR PERIOD. THE INVESTIGATION REVEALED THAT A PRELIMINARY ECG INTERPRETATION PROVIDED TO THE PHYSICIAN WAS MISCLASSIFIED. FOLLOWING THE WEAR PERIOD AND WHILE COMPILING THE FINAL REPORT, THE INTERPRETATION WAS AMENDED. THE HCP WAS NOTIFIED IMMEDIATELY, AND IRHYTHM LEARNED THAT THE HCP WAS ALREADY AWARE OF THE PATIENT'S ARRHYTHMIA AND WAS TREATING IT. NO ADVERSE EVENTS, SUCH AS DEATH OR SERIOUS INJURY, ARE KNOWN TO HAVE OCCURRED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 18862180 ↗
• MalfunctionMar 6, 2024Inaccurate Information; Inaccurate Information

  THE PATIENT EXPERIENCED AN ARRHYTHMIA THAT MET MEDICAL DOCTOR NOTIFICATION (MDN) REQUIREMENTS THAT WAS NOT COMMUNICATED DURING THE WEAR PERIOD. THE INVESTIGATION REVEALED THAT A PRELIMINARY ECG INTERPRETATION PROVIDED TO THE PHYSICIAN WAS MISCLASSIFIED. FOLLOWING THE WEAR PERIOD AND WHILE COMPILING THE FINAL REPORT, THE INTERPRETATION WAS AMENDED. THERE WERE NO DELAYS IN CARE, AND NO ADVERSE EVENTS, SUCH AS DEATH OR SERIOUS INJURY, ARE KNOWN TO HAVE OCCURRED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 18851559 ↗
• MalfunctionFeb 8, 2024Failure to Transmit Record; Inaccurate Information; Failure to Transmit Record; Inaccurate Information

  THE PATIENT EXPERIENCED AN ARRHYTHMIA THAT MET MEDICAL DOCTOR NOTIFICATION (MDN) REQUIREMENTS THAT WAS NOT COMMUNICATED DURING THE WEAR PERIOD. THE INVESTIGATION REVEALED THAT A PRELIMINARY ECG INTERPRETATION PROVIDED TO THE PHYSICIAN WAS MISCLASSIFIED. FOLLOWING THE WEAR PERIOD AND WHILE COMPILING THE FINAL REPORT, THE INTERPRETATION WAS AMENDED. THE HCP WAS NOTIFIED IMMEDIATELY, AND IRHYTHM LEARNED THAT THE HCP WAS ALREADY AWARE OF THE PATIENT'S ARRHYTHMIA AND WAS TREATING IT. NO ADVERSE EVENTS, SUCH AS DEATH OR SERIOUS INJURY, ARE KNOWN TO HAVE OCCURRED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 18672902 ↗
• MalfunctionFeb 5, 2024Failure to Transmit Record; Inaccurate Information; Failure to Transmit Record; Inaccurate Information

  THE PATIENT EXPERIENCED AN ARRHYTHMIA THAT MET MEDICAL DOCTOR NOTIFICATION (MDN) REQUIREMENTS THAT WAS NOT COMMUNICATED DURING THE WEAR PERIOD. THE INVESTIGATION REVEALED THAT A PRELIMINARY ECG INTERPRETATION PROVIDED TO THE PHYSICIAN WAS MISCLASSIFIED. FOLLOWING THE WEAR PERIOD AND WHILE COMPILING THE FINAL REPORT, THE INTERPRETATION WAS AMENDED. IRHYTHM COMPLETED THREE GOOD FAITH ATTEMPTS TO THE ACCOUNT TO OBTAIN ADDITIONAL INFORMATION, BUT WITH NO RESULT. IT IS UNKNOWN WHETHER THE PATIENT RECEIVED ANY TREATMENT FOR THE ARRHYTHMIA.

  Patient problems: Unspecified Heart Problem

  MAUDE report 18643264 ↗
• MalfunctionFeb 2, 2024Failure to Transmit Record; Failure to Transmit Record

  THE PATIENT EXPERIENCED AN ARRHYTHMIA THAT MET MEDICAL DOCTOR NOTIFICATION (MDN) REQUIREMENTS THAT WAS NOT TRANSMITTED DURING THE WEAR PERIOD. THE INVESTIGATION REVEALED A POTENTIAL ALGORITHM SENSITIVITY ISSUE WITH THE DEVICE. THE HEALTHCARE PROVIDER (HCP) WAS IMMEDIATELY NOTIFIED, AND IRHYTHM LEARNED THAT THE HCP WAS ALREADY AWARE OF THE PATIENT'S ARRHYTHMIA. THERE WERE NO DELAYS IN TREATMENT, AND NO ADVERSE EVENTS, SUCH AS DEATH OR SERIOUS INJURY, ARE KNOWN TO HAVE OCCURRED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 18636754 ↗
• MalfunctionJan 31, 2024Failure to Transmit Record; Inaccurate Information; Failure to Transmit Record; Inaccurate Information

  THE PATIENT EXPERIENCED AN ARRHYTHMIA THAT MET MEDICAL DOCTOR NOTIFICATION (MDN) REQUIREMENTS THAT WAS NOT COMMUNICATED DURING THE WEAR PERIOD. THE INVESTIGATION REVEALED THAT A PRELIMINARY ECG INTERPRETATION PROVIDED TO THE PHYSICIAN WAS MISCLASSIFIED. FOLLOWING THE WEAR PERIOD AND WHILE COMPILING THE FINAL REPORT, THE INTERPRETATION WAS AMENDED. IRHYTHM COMPLETED THREE GOOD FAITH ATTEMPTS TO THE ACCOUNT TO OBTAIN ADDITIONAL INFORMATION, BUT WITH NO RESULT. IT IS UNKNOWN WHETHER THE PATIENT RECEIVED ANY TREATMENT FOR THE ARRHYTHMIA.

  Patient problems: Unspecified Heart Problem

  MAUDE report 18619512 ↗
• MalfunctionJan 3, 2024Failure to Transmit Record; Failure to Transmit Record

  THE PATIENT EXPERIENCED AN ARRHYTHMIA THAT MET MEDICAL DOCTOR NOTIFICATION (MDN) REQUIREMENTS THAT WAS NOT TRANSMITTED DURING THE WEAR PERIOD. THE INVESTIGATION REVEALED A POTENTIAL ALGORITHM SENSITIVITY ISSUE WITH THE DEVICE. THE HEALTHCARE PROVIDER (HCP) WAS IMMEDIATELY NOTIFIED OF THE PATIENT'S ARRHYTHMIA, AND IRHYTHM WAS INFORMED THAT THE PATIENT IS NOT COMPLIANT WITH HIS MEDICAL RECOMMENDATIONS. THERE WERE NO DELAYS IN TREATMENT, AND NO ADVERSE EVENTS, SUCH AS DEATH OR SERIOUS INJURY, ARE KNOWN TO HAVE OCCURRED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 18440054 ↗
• MalfunctionDec 19, 2023Inaccurate Information; Inaccurate Information

  THE PATIENT EXPERIENCED AN ARRHYTHMIA THAT MET MEDICAL DOCTOR NOTIFICATION (MDN) REQUIREMENTS THAT WAS NOT COMMUNICATED DURING THE WEAR PERIOD. THE INVESTIGATION REVEALED THAT A PRELIMINARY ECG INTERPRETATION PROVIDED TO THE PHYSICIAN WAS MISCLASSIFIED. FOLLOWING THE WEAR PERIOD AND WHILE COMPILING THE FINAL REPORT, THE INTERPRETATION WAS AMENDED. THE HCP WAS NOTIFIED IMMEDIATELY, AND IRHYTHM LEARNED THAT THE HCP WAS ALREADY AWARE OF THE PATIENT'S ARRHYTHMIA AND WAS TREATING IT. NO ADVERSE EVENTS, SUCH AS DEATH OR SERIOUS INJURY, ARE KNOWN TO HAVE OCCURRED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 18354849 ↗
• MalfunctionDec 14, 2023Inaccurate Information; Inaccurate Information

  THE PATIENT EXPERIENCED AN ARRHYTHMIA THAT MET MEDICAL DOCTOR NOTIFICATION (MDN) REQUIREMENTS THAT WAS NOT COMMUNICATED DURING THE WEAR PERIOD. THE INVESTIGATION REVEALED THAT A PRELIMINARY ECG INTERPRETATION WAS MISCLASSIFIED. FOLLOWING THE WEAR PERIOD AND WHILE COMPILING THE FINAL REPORT, THE INTERPRETATION WAS AMENDED. THE HCP WAS NOTIFIED IMMEDIATELY, AND IRHYTHM LEARNED THAT THE HCP WAS ALREADY AWARE OF THE PATIENT'S ARRHYTHMIA AND WAS TREATING IT. NO ADVERSE EVENTS, SUCH AS DEATH OR SERIOUS INJURY, ARE KNOWN TO HAVE OCCURRED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 18331020 ↗