EP-WorkMateRecalls & reported problems across all models

We found 4 models of EP-WorkMate by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 24 adverse event reports in the FDA's MAUDE database, received between Jun 26, 2018 and May 9, 2025 — classified as 17 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (8 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported EP-WorkMate problems

EP-WorkMate models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• EP-WorkMate™ 100019209

  COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  14 reports
• EP-WorkMate™ System

  COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  5 reports
• EP-WorkMate™ Recording System

  COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  4 reports
• EP-WorkMate™ WM-01-1203

  COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  1 report

Recent EP-WorkMate adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2025Output Problem; Output Problem

  DURING A PROCEDURE, THE WORKMATE CLARIS COMPUTER DISPLAYED AN ERROR MESSAGE AND THE PROCEDURE WAS CANCELLED. THE OLD WORKMATE SYSTEM WAS REPLACED BY THE NEW ENSITE X VERSION OF WORKMATE CLARIS. THE ERROR MESSAGE THAT DISPLAYED WAS ERROR MESSAGE: "162-SYSTEM OPTIONS NOT SET. THE SYSTEM CONFIGURATION HAS CHANGED SINCE THE LAST BOOT. ADDITION OF A HARD DRIVE, ETC., OR LOSS OF POWER TO THE REAL TIME CLOCK HAS OCCURRED. PRESSING F1 WILL RECORD THE NEW CONFIGURATION. IF THIS MESSAGE PERSIST, YOU MAY NEED TO REPLACE THE ONBOARD BATTERY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21995035 ↗
• 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 ↗
• MalfunctionApr 5, 2021Failure to Analyze Signal; Failure to Analyze Signal

  DURING AN ATRIOVENTRICULAR NODAL RE-ENTRANT TACHYCARDIA (AVNRT) PROCEDURE, INTRACARDIAC SIGNALS WERE NOT VISIBLE WHEN THE AMPLIFIER WAS CONNECTED AND THE CASE WAS CANCELLED. THE FEMORAL VEIN WAS PUNCTURED AND CATHETERS WERE INSERTED AND NO INTRACARDIAC ELECTROGRAMS WERE NOTED. THE SYSTEM WAS RESTARTED 3 TIMES WHICH DID NOT RESOLVE THE ISSUE AND THE PROCEDURE WAS POSTPONED. ANOTHER SYSTEM WAS USED TO COMPLETE THE CASE THE NEXT DAY WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11614835 ↗
• InjurySep 9, 2020Failure to Power Up; Failure to Power Up

  DURING THE PROCEDURE, THE AMPLIFIER WOULD NOT BOOT UP AND ONE SINGLE CONTINUOUS BEEP WAS HEARD AND THE PROCEDURE WAS CANCELLED. THE AMPLIFIER WAS REBOOTED SEVERAL TIMES, BUT THE ISSUE REMAINED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT DUE TO THE CANCELLATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10508714 ↗
• 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 ↗
• InjuryAug 30, 2019Communication or Transmission Problem; Communication or Transmission Problem

  DURING A SUPRAVENTRICULAR TACHYCARDIA ABLATION PROCEDURE A CANCELLATION OCCURRED. FOLLOWING PATIENT PREP, THE AMPLIFIER WAS POWERED ON AND INTERMITTENT CONNECTION OCCURRED. THE AMPLIFIER AND MEDIA CONVERTER WERE POWER CYCLED WITHOUT RESOLUTION. THE FIBER OPTIC AND ETHERNET CABLES WERE REPLACED AND THE ISSUE STILL DID NOT IMPROVE. THE PROCEDURE WAS CANCELLED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8950654 ↗
• InjuryMay 22, 2019Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  DURING A PROCEDURE THE COMPUTER DISPLAYED A "WIN32" ERROR MESSAGE AND THE SOFTWARE STOPPED RUNNING. THE PROCEDURE WAS UNABLE TO BE COMPLETED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8633603 ↗
• 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 ↗

Other St. Jude Medical, Inc. products

• Tendril15 models · 49,498 reports
• Octrode10 models · 36,740 reports
• Proclaim12 models · 35,038 reports · 17 recalls
• Durata28 models · 19,805 reports
• Assurity MRI2 models · 17,838 reports · 1 recall
• Gallant8 models · 12,885 reports · 5 recalls
• Quartet10 models · 11,001 reports
• MitraClip19 models · 9,056 reports · 2 recalls