EP-WorkMate™ 100019209Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 05415067003126), received between Jul 13, 2018 and Mar 17, 2025 — classified as 11 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (6 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2025Signal Artifact/Noise; Signal Artifact/Noise

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, SIGNAL ISSUES RESULTED IN THE PROCEDURE BEING CANCELLED. WHEN THE CATHETERS WERE PLACED IN THE PATIENT, IT WAS REPORTED THAT THE INTRACARDIAC SIGNALS WERE NOT VISIBLE ON THE WORKMATE CLARIS AMPLIFIER AND KEPT DISPLAYING BLUE LINES. ONLY ECG SIGNALS WERE SHOWN AS ECM WOULD NOT DISPLAY. ISSUE WAS NOT RESOLVED, THEREFORE THE CASE WAS CANCELED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WILL BE RESCHEDULED FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21617911 ↗
• MalfunctionSep 12, 2022Signal Artifact/Noise; Communication or Transmission Problem; Signal Artifact/Noise; Communication or Transmission Problem

  DURING THE ATRIOVENTRICULAR NODAL RE-ENTRANT TACHYCARDIA PROCEDURE, SIGNALS WERE NOT VISIBLE RESULTING IN CANCELLATION OF THE PROCEDURE. AT THE BEGINNING OF THE PROCEDURE NORMAL NOISE APPEARED, HOWEVER, A BLUE LINE WAS PRESENT WHILE THE ECG TRACE WAS PRESENT AND CLEAN. IT WAS ONLY POSSIBLE TO VIEW THE SIGNALS IN NAVX MODE. THE SYSTEM WAS RESTARTED, THE AMPLIFIER WAS DIRECTLY CONNECTED TO BYPASS THE RECORDCONNECT WHICH DID NOT RESOLVE THE ISSUE AND THE PROCEDURE WAS CANCELLED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15403178 ↗
• InjuryJun 30, 2020No Display/Image; No Display/Image

  THERE WAS NO EGM DISPLAY ON THE WORKMATE CLARIS. THE CABLE CONNECTION WAS CHECKED AS WELL AS ANOTHER CABLE WHICH DID NOT RESOLVE THE ISSUE. THE STUDY WAS CANCELLED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10211328 ↗
• InjuryNov 21, 2019Communication or Transmission Problem; Communication or Transmission Problem

  FURTHER INFORMATION CONFIRMED THAT THE PATIENT WAS NOT PREPPED FOR THE PROCEDURE WHEN IT WAS CANCELLED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9356086 ↗
• InjurySep 19, 2019Failure to Analyze Signal; Failure to Analyze Signal

  DURING PACING THERE WAS NO SIGNAL DISPLAYED ON THE LIVE SCREEN WHEN THE CATHETER WAS CONNECTED TO THE PIN BOX. ALL CONNECTIONS WERE CHECKED, AND CABLING WAS REPLACED, BUT THE ISSUE REMAINED. THE PROCEDURE WAS CANCELLED AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. DURING FURTHER TROUBLESHOOTING, IT WAS FOUND THAT THE SYSTEM REFERENCE CABLE GOING INTO THE AMPLIFIER WAS LOOSE. ONCE THAT WAS TIGHTENED, THE ISSUE WAS RESOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9086651 ↗
• InjurySep 10, 2019Failure to Analyze Signal; Failure to Analyze Signal

  DURING A PROCEDURE A CANCELLATION OCCURRED DUE TO A LOSS OF SIGNAL FROM THE AMPLIFIER. TO RESOLVE THE ISSUE THE AMPLIFIER WAS POWER CYCLED BUT IT DID NOT PROPERLY STARTUP. ALL CONNECTIONS WERE CHECK BUT THE ISSUE WAS NOT RESOLVED. THE PROCEDURE WAS CANCELLED AND RESCHEDULED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8980076 ↗
• InjuryJan 30, 2019Output Problem; Output Problem

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE A CANCELLATION OCCURRED DUE TO AN AMPLIFIER ERROR. WHEN THE PATIENT WAS IN THE OPERATING ROOM, THE AMPLIFIER WAS DISPLAYING AN ALERT ALONG WITH AN AUDIBLE NOISE. THE ISSUE COULD NOT BE RESOLVED AND THE PROCEDURE WAS CANCELLED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8290135 ↗
• MalfunctionJan 10, 2019Sparking; Sparking

  PRIOR TO THE PROCEDURE A SPARK WAS SEEN WHEN THE AMPLIFIER WAS POWERED ON. THERE WERE NO ADVERSE CONSEQUENCES TO THE USER. THE PROCEDURE WAS RESCHEDULED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8233188 ↗
• InjuryDec 28, 2018Communication or Transmission Problem; Communication or Transmission Problem

  DURING AN ABLATION PROCEDURE, THE INTRACARDIAC SIGNALS WERE INTERMITTENTLY LOST. THE LEADS WERE CHECKED AND SECURE ON THE PATIENT. THE PROCEDURE WAS CANCELLED AND THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8204165 ↗
• InjuryDec 21, 2018Noise, Audible; Noise, Audible

  PRIOR TO THE PROCEDURE, THE AMPLIFIER WAS EMITTING A BEEPING TONE THAT COULD NOT BE RESOLVED AND THE PROCEDURE WAS CANCELLED. TROUBLESHOOTING WAS ATTEMPTED WITH NO RESOLUTION AND THE PROCEDURE WAS RESCHEDULED. THE PATIENT WAS NOT PREPARED BUT WAS IN THE ROOM AT THE TIME OF CANCELLATION. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8191304 ↗
• InjurySep 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIOR TO AN ELECTROPHYSIOLOGICAL EXPLORATION PROCEDURE, NO SIGNAL WAS NOTED ON THE SYSTEM AND THE PROCEDURE WAS CANCELLED. THE JUNCTION BOX AND CABLES WERE REPLACED WITH NO RESOLUTION. THE PROCEDURE WAS CANCELLED AND RESCHEDULED FOR A LATER DATE. THE PATIENT WAS IN THE ROOM BUT WAS NOT PREPARED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT DUE TO THE CANCELLATION. FURTHER TROUBLESHOOTING REVEALED THE SIGNAL LOSS WAS DUE TO USER ERROR. THE AMPLIFIER PASSED ALL FUNCTIONAL TESTS AND RETRAINING WILL BE PROVIDED TO THE CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7902526 ↗
• InjuryAug 8, 2018Communication or Transmission Problem; Communication or Transmission Problem

  DURING AN ATRIOVENTRICULAR NODAL REENTRY TACHYCARDIA PROCEDURE A CANCELLATION OCCURRED DUE TO SIGNAL LOSS. DURING THE PROCEDURE ECG AND INTRACARDIAC SIGNALS WERE NOT AVAILABLE. THE ISSUE COULD NOT BE RESOLVED AND THE PROCEDURE WAS CANCELLED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7761730 ↗
• InjuryAug 8, 2018Communication or Transmission Problem; Communication or Transmission Problem

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE A CANCELLATION OCCURRED DUE TO AMPLIFIER SIGNAL ERRORS. TO RESOLVE THE ISSUE THE SYSTEM CABLES WERE EXCHANGED, THE SYSTEM WAS RESTARTED AND THE IP ADDRESS WAS CHANGED BUT THERE WERE NO IMPROVEMENTS. THE PROCEDURE WAS CANCELLED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7761709 ↗
• InjuryJul 13, 2018Communication or Transmission Problem; Communication or Transmission Problem

  DURING AN ATRIAL FLUTTER ABLATION PROCEDURE A CANCELLATION OCCURRED DUE TO SIGNAL LOSS. FOLLOWING PATIENT PREPARATION ECG SIGNALS WERE DISPLAYED AS EXPECTED BUT WHEN THE CATHETER WAS CONNECTED TO THE RECORDING SYSTEM, NO INTRACARDIAC SIGNALS WERE AVAILABLE. THE PROCEDURE WAS CANCELLED. THERE WERE NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7685100 ↗