X SERIES 620-2241411-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00847946019372), received between Jun 3, 2019 and Sep 17, 2026 — classified as 3 deaths, 16 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (4 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026No Display/Image

  COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE'S SCREEN TURNED COMPLETELY WHITE AND WAS ILLEGIBLE.COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50806085 ↗
• MalfunctionAug 29, 2025Unexpected Shutdown; Unexpected Shutdown

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE INAPPROPRIATELY SHUT DOWN. ANOTHER DEVICE WAS USED. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22922976 ↗
• DeathJun 9, 2025Unexpected Shutdown; Unexpected Shutdown

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO PACE A PATIENT DURING A BRADYCARDIA EVENT (AGE & GENDER UNKNOWN), THE DEVICE INAPPROPRIATELY SHUT DOWN. AS THE PATIENT WAS BEING LOADED INTO THE BACK OF THE AMBULANCE, THE PATIENT WENT INTO CARDIAC ARREST. THE CLINICIAN PERFORMED RESUSCITATION EFFORTS TO CONTINUE TO TREAT THE PATIENT. THE COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

  Patient problems: Cardiac Arrest

  MAUDE report 22168051 ↗
• MalfunctionMar 5, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE ELECTRODE PADS WERE DAMAGED DURING OPENING OF PACKAGING. THE CREWS USED A 2ND SET OF PADS, AND NOTICED A SIMILAR ISSUE, BUT WERE ABLE TO SLOWLY PULL THE PADS FROM THE ADHESIVE BACKING IN ORDER TO KEEP THE ADHESIVE INTACT TO CONTINUE TREATING THE PATIENT. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: Insufficient Information

  MAUDE report 21525826 ↗
• MalfunctionJul 1, 2024Failure to Power Up; Failure to Power Up

  COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE WOULD NOT POWER UP. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19643975 ↗
• MalfunctionMar 7, 2024Failure to Charge; Failure to Charge

  COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED A "DEFIB CHARGING ERROR" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18856992 ↗
• MalfunctionJun 7, 2023Failure to Capture; Failure to Capture

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO PACE AN 85-YEAR-OLD MALE PATIENT, THE DEVICE FAILED TO CAPTURE THE PATIENT'S HEART RHYTHM. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: Muscle Weakness/Atrophy; Nausea

  MAUDE report 17080503 ↗
• DeathMay 9, 2023Failure to Charge; Failure to Charge

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A 67-YEAR-OLD MALE PATIENT, THE DEVICE FAILED TO CHARGE TO SET ENERGY. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

  Patient problems: Necrosis

  MAUDE report 16895063 ↗
• MalfunctionOct 18, 2022Failure of Device to Self-Test; Failure of Device to Self-Test

  COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE FAILED SELF-TEST FOR PACER FUNCTION. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15625923 ↗
• MalfunctionMay 18, 2022No Display/Image; No Display/Image

  COMPLAINANT ALLEGED THAT DURING ONSITE TRAINING, THE DEVICE'S SCREEN TURNED COMPLETELY WHITE AND WAS ILLEGIBLE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14428754 ↗
• MalfunctionMay 16, 2022Unable to Obtain Readings; Unable to Obtain Readings

  COMPLAINANT ALLEGED THAT DURING TRAINING BT STAFF, THE DEVICE WAS UNABLE TO AN OBTAIN ECG SIGNAL. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14413596 ↗
• MalfunctionApr 11, 2022Pacing Problem; Pacing Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO PACE A (B)(6)YEAR-OLD FEMALE PATIENT, THE DEVICE DID NOT HAVE PACER OUTPUT. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14077448 ↗
• MalfunctionSep 29, 2021Pacing Problem; Pacing Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO PACE A (B)(6)-YEAR-OLD FEMALE PATIENT, THE DEVICE WAS UNABLE TO PACE. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: Insufficient Information

  MAUDE report 12549262 ↗
• MalfunctionAug 16, 2021Pacing Problem; Pacing Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO PACE A 53-YEAR-OLD MALE PATIENT, THE DEVICE WAS UNABLE TO CAPTURE. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12328154 ↗
• MalfunctionJul 30, 2021Failure to Charge; Failure to Charge

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A (B)(6) FEMALE PATIENT, THE DEVICE FAILED TO CHARGE. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12256239 ↗
• DeathFeb 12, 2021Pacing Problem; Pacing Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO PACE A (B)(6) FEMALE PATIENT, THE DEVICE WAS UNABLE TO PACE. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

  Patient problems: Necrosis

  MAUDE report 11322701 ↗
• MalfunctionJul 27, 2020No Display/Image; No Display/Image

  COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE'S SCREEN TURNED COMPLETELY WHITE AND WAS ILLEGIBLE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 10326304 ↗
• MalfunctionApr 24, 2020Failure to Power Up; Failure to Power Up

  COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE WOULD NOT FULLY POWER UP. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 9996797 ↗
• MalfunctionJun 3, 2019Failure to Power Up; Failure to Power Up

  COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE WOULD NOT POWER UP. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 8662575 ↗