EP-4™ Cardiac StimulatorRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05414734208741), received between Dec 27, 2018 and Jul 5, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 5, 2023Pacing Problem; Impedance Problem; Pacing Problem; Impedance Problem

  DURING THE SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, PACING AND IMPEDANCE ISSUES RESULTED IN THE PROCEDURE BEING ABANDONED WITH NO REPORTED ADVERSE PATIENT CONSEQUENCES. IT WAS NOTED THAT THE PACING SPIKE WAS NOT BEING DELIVERED PROPERLY TO THE TISSUE. THE PACING SPIKE WAS VISIBLE ON THE NON-ABBOTT SYSTEM (CARDIOLAB), BUT THERE WAS NO RESPONSE FROM THE TISSUE. THE TOUCHSCREEN SHOWED AN IMPEDANCE ERROR AND "CHECK OUTPUTS SWITCHES" ERROR. THE PROCEDURE WAS NOT ABLE TO BE COMPLETED AND THEREFORE ABANDONED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17256219 ↗
• MalfunctionSep 28, 2022Pacing Problem; Pacing Problem

  DURING A PROCEDURE, PACEMAKERS WERE PRESENT DURING PACING, HOWEVER, THERE WAS NO CAPTURE. PACING WAS DONE AT 10MA/2MS, THEN INCREASED TO 20MA/2MS WHICH DID NOT RESOLVE AND PACING COULD BE DONE ON ALL CHANNELS. THE STIM CABLES WERE DISCONNECTED AND RECONNECTED WHICH DID NOT RESOLVE THE ISSUE. THE SYSTEM WAS POWER CYCLED, THE BNC CABLE CONNECTION FROM THE EP-4 TO THE CARTO SYSTEM WAS CHECKED AND CONFIRMED TO BE OK. THE ISSUE DID NOT RESOLVE AND THE PROCEDURE WAS ABORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15496594 ↗
• InjuryDec 27, 2018Output Problem; Output Problem

  DURING AN ABLATION PROCEDURE, THE ERROR MESSAGE "EP4 IS NOT RESPONDING - HARDWARE IS NOT RESPONDING" WAS DISPLAYED ON THE TOUCH SCREEN. THE DEVICE WAS POWER-CYCLED; HOWEVER, IT DID NOT PASS THE SELF TEST AND RETURNED TO THE MAIN MENU ON THE TOUCH SCREEN. THE PROCEDURE WAS CANCELLED AND THERE WERE NO ADVERSE PATIENT CONSEQUENCES. RECONNECTING THE CABLES AFTER THE PROCEDURE RESOLVED THE ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8200499 ↗