NA 5392 (UDI 00763000162443)Recalls & reported problems

Summary

The FDA's MAUDE database contains 504 adverse event reports that list this exact device (DI 00763000162443), received between Feb 27, 2019 and Sep 29, 2026 — classified as 32 injuries, 472 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (80 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 504 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Mechanical Problem

  It was reported that the External Pulse Generator (EPG)'s battery door was broken. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927983 ↗
• MalfunctionSep 25, 2026Mechanical Problem

  It was further noted that there was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898452 ↗
• MalfunctionSep 25, 2026Failure to Capture; Device Sensing Problem

  It was reported that the External Pulse Generator (EPG) and the pacing cables experienced loss of capture and sensing while in use with pacer-dependent patients during surgeries. It was noted that the cables and the EPG were used successfully in other rooms, so the issue might have been related to electromagnetic interference from new vein-harvesting equipment being used in the operating room. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895634 ↗
• MalfunctionSep 25, 2026No Display/Image

  It was reported that the External Pulse Generator (EPG) flickered on and off when turned on. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50894272 ↗
• MalfunctionSep 25, 2026Calibration Problem

  It was reported that the External Pulse Generator (EPG)'s Ventricular knob was not adjusting voltage when turned. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50893814 ↗
• MalfunctionSep 17, 2026Mechanical Problem

  It was reported that the External Pulse Generator (EPG)'s battery drawer was broken and was not able to hold the battery in place. It was noted that the EPG's functionality was limited. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50807322 ↗
• MalfunctionSep 8, 2026Break; Failure to Power Up

  It was reported that the External Pulse Generator (EPG) was unable to turn on and Intravenous (IV) pole hanger was broken. The EPG has been returned for evaluation and subsequently tested out of specification during manufacturer's analysis. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50664820 ↗
• MalfunctionSep 8, 2026Output Problem

  It was reported that the External Pulse Generator (EPG) was unable to read 0 -10 milliamperes during preventive checks for the output tests. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50661780 ↗
• MalfunctionSep 8, 2026Output Problem

  It was reported that the External Pulse Generator (EPG) was unable to read 0 -10 milliamperes during preventive checks for the output tests. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50661779 ↗
• MalfunctionAug 31, 2026No Display/Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50519575 ↗
• MalfunctionAug 28, 2026Device Sensing Problem

  It was reported that the External Pulse Generator (EPG) incorrectly sensed the T wave and delivered pacing output. It was noted that the sense amplitude function was not working correctly.No patient complications have been reported as a result of this event.

  Patient problems: Arrhythmia; Cardiac Arrest; No Clinical Signs, Symptoms or Conditions; Ventricular Fibrillation

  MAUDE report 50501939 ↗
• MalfunctionAug 24, 2026Calibration Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50410732 ↗
• InjuryAug 24, 2026Output Problem

  It was reported that the External Pulse Generator (EPG) paced on the T wave while connected to the patient and that the EPG was set to ventricular demand mode (VVI) at 60 beats per minute (bpm), which was reported to have caused Torsades de Pointes. It was noted that the EPG was pacing at a rate higher than the patient's intrinsic heart rate. No further patient complications have been reported as a result of this event.

  Patient problems: Arrhythmia

  MAUDE report 50402777 ↗
• MalfunctionAug 18, 2026Mechanical Problem

  It was reported that the External Pulse Generator (EPG)'s battery drawer was unable to hold the batteries in place. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50300531 ↗
• MalfunctionAug 16, 2026Unexpected Shutdown

  It was reported that the External Pulse Generator (EPG) turned off while connected to the patient. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50268254 ↗
• MalfunctionAug 12, 2026Connection Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50223962 ↗
• MalfunctionAug 12, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50219000 ↗
• MalfunctionAug 11, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50206669 ↗
• MalfunctionJul 8, 2026Connection Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25753099 ↗
• MalfunctionJun 24, 2026Device Sensing Problem

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) FAILED THE THE SENSITIVITY TEST. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25604122 ↗
• MalfunctionJun 24, 2026Device Sensing Problem

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) FAILED THE THE SENSITIVITY TEST. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25604121 ↗
• MalfunctionJun 11, 2026Device Sensing Problem

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) VENTRICULAR SENSITIVITY TESTED OUT OF RANGE FOR BOTH THE 10 MILLIVOLT (MV) AND 20 MILLIVOLT (MV) SETTINGS. IT WAS NOTED THAT THE TEST RESULT AT 2 MILLIVOLT (MV) WERE IN RANGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25468848 ↗
• MalfunctionJun 10, 2026Crack

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG)'S SCREEN WAS CRACKED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25453015 ↗
• MalfunctionMay 25, 2026No Display/Image; Mechanical Problem

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG)'S SCREEN WAS BROKEN AND THE GASKET CAME OUT OF CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25268591 ↗
• MalfunctionMay 22, 2026Unexpected Shutdown

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) RANDOMLY POWERED OFF WITH NEW BATTERIES BEING INSTALLED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25253909 ↗