NA 5392 (UDI 00643169725126)Recalls & reported problems

Summary

The FDA's MAUDE database contains 654 adverse event reports that list this exact device (DI 00643169725126), received between Jun 8, 2017 and Sep 18, 2026 — classified as 2 deaths, 35 injuries, 617 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (220 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 25 most recent of 654 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Break; Mechanical Problem; Connection Problem

  It was reported that the External Pulse Generator (EPG)'s battery compartment was cracked on the bottom. The EPG was returned for ev aluation and subsequently tested out of specification during the manufacturer's analysis. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50816158 ↗
• MalfunctionSep 11, 2026No Display/Image

  It was reported that the External Pulse Generator's (EPG) top screen was unable to turn on during preventive maintenance. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50726369 ↗
• MalfunctionAug 17, 2026Output Problem

  It was reported that the External Pulse Generator (EPG) delivered inappropriate pacing. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50269048 ↗
• MalfunctionJul 2, 2026Connection Problem

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG)'S ATRIAL PORT WAS WORN OUT AND WAS UNABLE TO HOLD CABLE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25686759 ↗
• MalfunctionMay 21, 2026Break; Calibration Problem

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG)'S FRONT CASE WAS BROKEN AND THE CONTROL KNOB WAS NON FUNCTIONAL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25238279 ↗
• MalfunctionMay 18, 2026Use of Device Problem

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) HAD AN ISSUE AND WAS UNABLE TO WORK AS EXPECTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25198202 ↗
• MalfunctionApr 7, 2026Connection Problem

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG)'S ATRIAL CONNECTOR WAS CRACKED AND WOULD NOT LATCH WHEN THE LEADS WERE ATTACHED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24801056 ↗
• MalfunctionMar 26, 2026No Display/Image

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24695445 ↗
• MalfunctionMar 17, 2026Connection Problem

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR'S (EPG) CONNECTOR FOR THE CABLE PLUG-INS WAS DAMAGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24615388 ↗
• MalfunctionMar 17, 2026Output Problem

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG)'S VENTRICULAR OUTPUT DID NOT MEET THE SPECIFICATION DURING PREVENTATIVE MAINTENANCE. IT WAS NOTED THAT THE ISSUE PERSISTED EVEN AFTER THE BATTERIES WERE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24615361 ↗
• MalfunctionMar 4, 2026Calibration Problem

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) HAD A KNOB ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24504439 ↗
• MalfunctionFeb 20, 2026Failure to Power Up; Unexpected Shutdown

  IT WAS FURTHER NOTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24398156 ↗
• MalfunctionJan 30, 2026Connection Problem

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG)'S ATRIAL AND VENTRICULAR CONNECTORS WERE BROKEN, PREVENTING THE CABLE FROM STAYING ATTACHED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24219696 ↗
• MalfunctionJan 13, 2026Crack; No Display/Image

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) HAD A CRACKED AND BROKEN DISPLAY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24052990 ↗
• MalfunctionDec 4, 2025Connection Problem; Material Integrity Problem; Connection Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG)'S ATRIAL AND VENTRICULAR PORTS PLASTIC CLIP WERE WORN OFF. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23717188 ↗
• MalfunctionNov 13, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG)'S BOTH THE UPPER AND LOWER DISPLAYS HAD A FADED OR DIM APPEARANCE. IT WAS NOTED THAT AN ATTEMPT WAS MADE TO REPLACE AND USE NEW BATTERIES, BUT THE ISSUE PERSISTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23543425 ↗
• MalfunctionNov 11, 2025Mechanical Problem; Mechanical Problem

  IT WAS FURTHER REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23520431 ↗
• MalfunctionOct 15, 2025Display or Visual Feedback Problem; Unexpected Shutdown; Display or Visual Feedback Problem; Unexpected Shutdown

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) DISPLAYED AN ERROR CODE. THE EPG HAS BEEN RETURNED FOR EVALUATION AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS.. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23280868 ↗
• MalfunctionSep 18, 2025No Display/Image; Failure to Power Up; No Display/Image; Failure to Power Up

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) WAS UNABLE TO TURN ON. IT WAS NOTED THAT THE SCREEN APPEARED TO POWER ON BUT THEN WENT DARK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23083165 ↗
• MalfunctionSep 9, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR'S (EPG) ATRIAL PORT WAS DAMAGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23004520 ↗
• InjurySep 3, 2025Device Sensing Problem; Output Problem; Device Sensing Problem; Output Problem

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) WAS NOT WORKING CORRECTLY AND PATIENT EXPERIENCED VENTRICULAR FIBRILLATION (VF). IT WAS NOTED THAT THE EPG FAILED THE VENTRICULAR CURRENT OUTPUT, ATRIAL CURRENT OUTPUT, AND VENTRICULAR SENSITIVITY TESTS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Ventricular Fibrillation

  MAUDE report 22950961 ↗
• InjurySep 3, 2025Device Sensing Problem; Output Problem; Device Sensing Problem; Output Problem

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) CAUSED THE VENTRICULAR FIBRILLATION TO THE PATIENT. IT WAS ALSO REPORTED THAT EPG FAILED IN VENTRICULAR CURRENT OUTPUT, ATRIAL CURRENT OUTPUT, AND VENTRICULAR SENSITIVITY TESTS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Ventricular Fibrillation

  MAUDE report 22950948 ↗
• MalfunctionAug 27, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR'S (EPG) ATRIAL CONNECTOR WAS DAMAGED. THE EPG WAS RETURNED FOR EVALUATION AND SUBS EQUENTLY TESTED OUT OF SPECIFICATION DURING THE MANUFACTURER'S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22903553 ↗
• MalfunctionAug 21, 2025Capturing Problem; Capturing Problem

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) WAS UNABLE TO CAPTURE CORRECTLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22858402 ↗
• MalfunctionAug 14, 2025Crack; Crack

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR'S (EPG) BOTTOM SCREEN WAS CRACKED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22804840 ↗