NA 53401Recalls & reported problems

Summary

The FDA's MAUDE database contains 133 adverse event reports that list this exact device (DI 00643169723160), received between Dec 7, 2017 and May 3, 2026 — classified as 8 injuries, 125 malfunctions.

The most frequently reported specific device problem is “Output Problem” (26 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 133 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 3, 2026Device Sensing Problem

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) VENTRICULAR SENSITIVITY AT 10 MV WAS OUT OF TOLERANCE DURING THE CHECKOUT TEST. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25062993 ↗
• MalfunctionApr 24, 2026Output above Specifications

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) OUTPUT MEASURED HIGHER THAN EXPECTED, AS THE ANALYZER DID NOT REGISTER BELOW 2.7 MILLIAMPERE WHEN SET TO 1 MILLIAMPERE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24979275 ↗
• MalfunctionApr 13, 2026Output Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24854881 ↗
• MalfunctionApr 1, 2026Output Problem

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) EXHIBITED INCONSISTENT OUTPUT DURING SERVICING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24751573 ↗
• MalfunctionFeb 11, 2026Calibration Problem

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) VENTRICULAR KNOB DID NOT ALWAYS CHANGE PARAMETERS WHEN TURNED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24319604 ↗
• MalfunctionDec 17, 2025Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE THE EXTERNAL PULSE GENERATOR (EPG) FAILED THE PULSE WIDTH TEST AT A RATE OF 30 BEATS PER MINUTE (BPM), WAS UNABLE TO PROVIDE A READING AT 30 BPM, AND ALSO FAILED THE SENSITIVITY TEST AT THE LOWEST SETTING, AS NO READING COULD BE OBTAINED ON THE TESTER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23825374 ↗
• MalfunctionDec 4, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR¿S (EPG) DISPLAY WAS COMPLETELY BLANK AFTER IT WAS TURNED ON. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23714717 ↗
• InjuryNov 10, 2025Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) SPONTANEOUSLY TURNED OFF WHILE IN USE WITH A PATIENT. IT WAS OBSERVED THAT THE PATIENT'S HEAR RATE WAS DROPPED TO 30 BEATS PER MINUTE (BPM). THE EPG WAS TURNED ON AND THEN SWAPPED WITH ALTERNATIVE EPG. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 23510915 ↗
• MalfunctionOct 21, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR¿S (EPG) OUTPUT MILLIAMPERE (MA) WAS UNABLE TO CHANGE EVEN DESPITE THE MA KNOB BEING ADJUSTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23348810 ↗
• MalfunctionSep 12, 2025Display or Visual Feedback Problem; Pacing Intermittently; Display or Visual Feedback Problem; Pacing Intermittently

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) HAD INTERMITTENT OUTPUT DURING TESTING. IT WAS NOTED THAT EPG DISPLAYED AN ERROR CODE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23036217 ↗
• MalfunctionSep 3, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE EXTERNAL PULSE GENERATOR (EPG) WAS RETURNED FOR TEST AND CALIBRATION 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 22949189 ↗
• MalfunctionApr 25, 2025Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) SHUT DOWN DURING THE SURGICAL PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21906631 ↗
• MalfunctionMar 10, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR'S (EPG) DISPLAY WAS BLANK WHEN IT WAS TURNED ON. TROUBLESHOOTING STEPS WERE TAKEN TO INCLUDE PERFORMING A POWER CYCLE AND CHANGING TO NEW BATTERIES, HOWEVER THE ISSUE PERSISTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21561146 ↗
• MalfunctionMar 4, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR'S (EPG) BATTERY DOOR WAS CRACKED AND DAMAGED, CAUSING THE BATTERY CONTACT TO FALL OUT. IT WAS ALSO NOTED THAT THE EPG'S OUTER COVER WAS MISSING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21513256 ↗
• MalfunctionFeb 4, 2025Output above Specifications; Output above Specifications

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) FAILED TESTING AT 1 MILLIAMP (MA) AS IT PRODUCED AN OUTPUT OF 2.5 MILLIAMPS (MA) AND REQUIRED CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21304646 ↗
• MalfunctionNov 11, 2024Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) POWERED OFF UNEXPECTEDLY A FEW MINUTES AFTER POWERING ON. THE EPG WAS CHECKED SEVERAL TIMES HOWEVER THE ISSUE PERSISTED AFTER CHANGING THE EPG BATTERIES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20651303 ↗
• MalfunctionOct 10, 2024Calibration Problem; Calibration Problem

  THE EXTERNAL PULSE GENERATOR (EPG) WAS RETURNED FOR PREVENTIVE MAINTENANCE AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUF ACTURER'S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20415171 ↗
• MalfunctionOct 7, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE EXTERNAL PULSE GENERATOR (EPG) WHICH WAS RETURNED FOR PREVENTIVE MAINTENANCE SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20381801 ↗
• MalfunctionAug 22, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) WHICH WAS RETURNED FOR PREVENTIVE MAINTENANCE SUBSEQUENTLY TESTED OUT OF SPE CIFICATION DURING MANUFACTURER¿S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20032243 ↗
• MalfunctionJun 4, 2024Use of Device Problem; Device Sensing Problem; Use of Device Problem; Device Sensing Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19457557 ↗
• MalfunctionMar 28, 2024Output Problem; Output Problem

  IT WAS REPORTED THAT EXTERNAL PULSE GENERATOR'S OUTPUTS WERE NOT CONSISTENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18993414 ↗
• MalfunctionMar 27, 2024No Device Output; No Device Output

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18986864 ↗
• MalfunctionMar 26, 2024Output Problem; Output Problem

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) WAS UNABLE TO MAINTAIN THE PROGRAMMED RATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18977204 ↗
• MalfunctionMar 7, 2024Electrical /Electronic Property Problem; Failure to Power Up; Electrical /Electronic Property Problem; Failure to Power Up

  IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) WAS UNABLE TO TURN ON. THE EPG WAS 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 18855375 ↗
• MalfunctionFeb 23, 2024No Device Output; No Device Output

  THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18765568 ↗