EP-4™ H21911Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 05414734219112), received between Jun 26, 2018 and May 17, 2023 — classified as 6 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Smoking” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMay 17, 2023No Tactile Prompts/Feedback; No Tactile Prompts/Feedback

  DURING AN ATRIAL FLUTTER PROCEDURE, THE STIMULATOR WAS UNRESPONSIVE TO A COMMAND TO STOP PACING RESULTING IN THE PATIENT EXPERIENCING ATRIAL FIBRILLATION WHICH REQUIRED CARDIOVERSION TO RESOLVE THE ATRIAL FIBRILLATION. THE STIMULATOR WAS TURNED OFF AND REBOOTED AND THE ISSUE WAS RESOLVED WITH NO FURTHER PATIENT CONSEQUENCES. THE PHYSICIAN WAS PACING DOWN TO A RATE IN THE 200S, THEN THE STIMULATOR SWITCHED TO PACING ON CHANNEL 3 AT 340 ON ITS OWN. WHEN THE COMMAND TO STOP PACING WAS GIVEN VIA THE KEYBOARD, IT DID NOT STOP PACING. IT WAS ATTEMPTED TO STOP PACING USING THE TOUCHSCREEN BUT THIS WAS ALSO UNSUCCESSFUL. WHILE THIS ISSUE WAS OCCURRING, THE SYSTEM AND TOUCHSCREEN DISPLAYS SHOWED A GREEN STIM BAR, INDICATING THE SYSTEM DID NOT THINK IT WAS PACING, EVEN THOUGH IT WAS. THE CONTINUED PACING CAUSED THE PATIENT TO BE PUT INTO ATRIAL FIBRILLATION. THE STIMULATOR WAS TURNED OFF WHICH STOPPED THE PACING. THE SYSTEM WAS REBOOTED AND THE ISSUE WAS RESOLVED. CARDIOVERSION WAS PERFORMED TO RESOLVE THE ATRIAL FIBRILLATION. THE PROCEDURE WAS COMPLETED WITH NO OTHER CONSEQUENCES.

  Patient problems: Atrial Fibrillation

  MAUDE report 16948120 ↗
• MalfunctionDec 20, 2022No Tactile Prompts/Feedback; No Tactile Prompts/Feedback

  DURING AN ATRIAL FIBRILLATION PROCEDURE, IT WAS NOTED THAT THE EP-4 STIMULATOR WAS SHOWING AS OFF AND NOT RESPONDING TO TOUCHSCREEN INPUTS WHICH CAUSED THE PROCEDURE TO BE CANCELLED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16015272 ↗
• MalfunctionDec 5, 2021Power Problem; Power Problem

  DURING THE ATRIAL FLUTTER PROCEDURE, THE EP4 TOUCHSCREEN KEPT LOOPING INTO WINDOWS BOOT SO THAT IT COULD NOT STIMULATE OR PACE. THE TOUCHSCREEN WAS BYPASSED AND CONNECTED DIRECTLY TO CLARIS CPU AND CONFIGURED TO WORK WITH CLARIS PROGRAM. THE CASE WAS CANCELLED DUE TO THIS ISSUE. A REPLACEMENT TOUCHSCREEN WAS RECEIVED AND INSTALLED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12931247 ↗
• InjurySep 23, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  DURING THE PROCEDURE, THE EP-4 STIMULATOR STARTED TO PACE AND WAS THOUGHT TO HAVE INDUCED THE PATIENT INTO VENTRICULAR FIBRILLATION DUE TO THE ISSUE. THE UNINTENDED STIMULATION WAS ABLE TO BE STOPPED ONCE IT WAS DISCOVERED AND DEFIBRILLATION WAS USED TO RESTORE THE PATIENT INTO SINUS RHYTHM. THE INDUCTION OF THE VENTRICULAR FIBRILLATION WAS NOTED TO HAVE BEEN CAUSED BY THE USER AND AN IMPROPER WORKFLOW OF THE DEVICE AND THERE WAS NO PERFORMANCE ISSUE WITH THE DEVICE. FURTHER INFORMATION ON THE EVENT IS UNAVAILABLE DESPITE ATTEMPTS TO GATHER THE INFORMATION.

  Patient problems: Arrhythmia

  MAUDE report 12518050 ↗
• MalfunctionMar 8, 2021Output Problem; Output Problem

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, A DELAY IN THE PROCEDURE OCCURRED DUE TO AN ERROR MESSAGE DISPLAYED ON THE EP-4 TOUCHSCREEN. ALL CABLE CONNECTIONS WERE VERIFIED AND THE ISSUE REMAINED. THE PROCEDURE WAS COMPLETED THE SAME DAY FOLLOWING A VISIT FROM THE ENGINEER TO FIX A LOOSE POWER SUPPLY ON THE EP-4 STIMULATOR. THERE WERE NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11440177 ↗
• InjuryJul 24, 2019Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  DURING A PULMONARY VEIN ISOLATION PROCEDURE, WITH THE PATIENT PREPPED FOR THE PROCEDURE, THE EP-4 TOUCHPAD DID NOT TURN ON DURING SET UP. A DIRECT CONNECTION TO THE COMPUTER WAS ATTEMPTED TO RESOLVE THE ISSUE BUT IT WAS DECIDED TO CANCEL THE CASE DUE TO NO STIMULATION FROM THE SYSTEM. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8823133 ↗
• InjuryMay 6, 2019Smoking; Smoking

  THE TOUCH SCREEN INTERFACE WAS SMOKING FROM THE BACK TOP RIGHT OF THE MONITOR PRIOR TO THE PROCEDURE. THE SYSTEM HAD BEEN ON FOR ABOUT 15-20 MINUTES AND ALL THE SUDDEN STARTED SMOKING. IT WAS UNPLUGGED FROM THE POWER AND BYPASSED DIRECTLY TO THE WORKMATE CPU AND THE CASE WAS COMPLETED WITH NO FURTHER ISSUES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8582516 ↗
• InjuryApr 5, 2019Pacing Problem; Pacing Problem

  RELATED MANUFACTURING REF: 2184149-2019-00040. NEAR THE END OF A PREMATURE VENTRICULAR CONTRACTION (PVC) PROCEDURE, THE TOUCHSCREEN COMPUTER DELIVERED SIX STIMULI TO THE PATIENT INSTEAD OF THREE AND INDUCED VENTRICULAR FIBRILLATION. THE PATIENT WENT INTO VENTRICULAR FIBRILLATION AND CARDIOVERSION WAS REQUIRED TO STABILIZE THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT IS IN STABLE CONDITION.

  Patient problems: Ventricular Fibrillation

  MAUDE report 8487017 ↗
• InjuryJan 30, 2019Communication or Transmission Problem; Communication or Transmission Problem

  DURING AN ACCESSORY PATHWAY ABLATION PROCEDURE, THE STIMULATOR DISPLAYED THE ERROR MESSAGE ¿EP-4 STIMULATOR HARDWARE IS NOT CONNECTED¿ AND THE PROCEDURE WAS CANCELLED. ONLY THE MAIN SCREEN DISPLAYED ON THE TOUCHSCREEN AND IT WAS NOT POSSIBLE TO CHANGE THE DIFFERENT STIMULATION PROTOCOLS SO THE PROCEDURE WAS RESCHEDULED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT DUE TO THE CANCELLATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8288488 ↗
• MalfunctionAug 1, 2018Smoking; Smoking

  WHILE POSITIONING THE CATHETERS AND COLLECTING GEOMETRY WITH THE MAPPING SYSTEM, THE TOUCH SCREEN COMPUTER SHUT DOWN AND EMITTED A BURNING SMELL AND SMOKE. THE PROCEDURE WAS COMPLETED WITHOUT THE TOUCH SCREEN COMPUTER AND THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7737941 ↗
• MalfunctionJul 18, 2018Smoking; Smoking

  PRIOR TO THE PROCEDURE, WHEN THE TOUCHSCREEN COMPUTER WAS POWERED ON SMOKE WAS NOTED TO BE COMING FROM THE DEVICE. THERE WERE NO ADVERSE CONSEQUENCES TO THE STAFF AND NO PATIENT WAS INVOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7697921 ↗
• MalfunctionJun 26, 2018Smoking; Smoking

  DURING DEVICE PREPARATION, SMOKE EMITTED FROM THE BACK OF THE TOUCHSCREEN. THERE WAS NO PATIENT INVOLVED, THEREFORE THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Patient Involvement

  MAUDE report 7637483 ↗