WorkMate Claris™ H700150Recalls & reported problems

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 05415067001504), received between Aug 30, 2018 and Aug 19, 2026 — classified as 18 injuries, 54 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (53 reports).

3 other recalls cover devices cleared under the same FDA submission (K132073, K210392); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 72 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 2026Communication or Transmission Problem

  During the procedure, after the patient was prepped, a cancellation was noted after the WorkMate Claris amplifier would not display the ECG signals. The WorkMate Claris amplifier was showing a connection with the DWS live screen, however the ECG signals would not display. The WorkMate Claris amplifier was restarted but the issue persisted. The procedure was cancelled with no adverse patient health consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50324540 ↗
• MalfunctionAug 14, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50256800 ↗
• MalfunctionMar 12, 2026Communication or Transmission Problem

  DURING THE NON-ABBOTT PFA (BOSTON SCIENTIFIC) PROCEDURE, COMMUNICATION ISSUES RESULTED IN THE CANCELLATION OF THE PROCEDURE. THERE WERE ISSUES WITH THE DWS FREEZING. LOG REVIEW OF THE DWS INDICATED THAT THE PFA WAS CAUSING ISSUES WITH THE AMPLIFIER THAT WAS CAUSING THE DWS TO FREEZE. IT WAS NOT POSSIBLE TO ACCESS THE WORKMATE CLARIS COMPUTER TO PACE, AND IT WAS NOT POSSIBLE TO CONFIRM BLOCK ON THE CTI LINE. THE PROCEDURE WAS NOT COMPLETED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24586328 ↗
• MalfunctionJan 22, 2026Communication or Transmission Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE USING RF, COMMUNICATION ISSUES RESULTED IN A PROCEDURAL DELAY. IT WAS NOTED THAT THE WORKMATE CLARIS AMPLIFIER WAS INTERMITTENTLY DISCONNECTING FROM THE WORKMATE DWS. THE RED LINE THAT NORMALLY DISPLAYED DURING RF, STIMULATION, AND CV WAS NOT DISPLAYING. THE MEDIA CONVERTER AND THE POWER SUPPLY WERE REPLACED, BUT THE ISSUE WAS NOT RESOLVED. REBOOTING THE WORKMATE DWS 4 TIMES RESOLVED THE ISSUE TO COMPLETE THE PROCEDURE. LATER IT WAS DETERMINED THAT THE AMPLIFIER WAS CAUSING THE ISSUE AND THE AMPLIFIER WAS REPLACED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24146329 ↗
• MalfunctionJan 21, 2026Communication or Transmission Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, WITH THE PATIENT ON THE TABLE, USING CRYOABLATION, IT WAS NOTED THAT THE WORKMATE CLARIS AMPLIFIER WAS NOT COMMUNICATING WITH THE DWS. TROUBLESHOOTING INCLUDED CHANGING THE FIBER OPTIC CABLE, BUT THE ISSUE PERSISTED. THE PROCEDURE WAS ABANDONED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24130551 ↗
• MalfunctionSep 17, 2025Communication or Transmission Problem; Communication or Transmission Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE WORKMATE CLARIS AMPLIFIER LOST CONNECTION RESULTING IN CANCELLATION OF THE PROCEDURE. THE CONNECTION COULD ONLY BE REESTABLISHED BY RESTARTING THE AMPLIFIER. THE PROCEDURE WAS ABANDONED, AND THE PATIENT WAS IN THE ROOM WHEN THE DECISION WAS MADE. THESE EVENTS OCCURRED IMMEDIATELY AFTER THE SYSTEM WAS MOVED INTO THE NEW LAB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23070113 ↗
• MalfunctionSep 2, 2025Communication or Transmission Problem; Communication or Transmission Problem

  DURING AN SVT PROCEDURE AFTER THE PATIENT WAS PREPPED, IT WAS REPORTED THAT THERE WAS NO COMMUNICATION BETWEEN THE WORKMATE CLARIS AMPLIFIER AND THE DWS CAUSING A DELAY. THE ISSUE WAS RESOLVED AFTER RESTARTING THE WORKMATE CLARIS SYSTEM THREE TIMES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22948557 ↗
• MalfunctionAug 24, 2025Signal Artifact/Noise; Signal Artifact/Noise

  DURING AN ATRIAL FLUTTER PROCEDURE, NOISE WAS NOTED DURING ABLATION RESULTING IN A DELAY. THE PROCEDURE WAS STOPPED DUE TO UNCERTAINTY AND MOVED TO ANOTHER OPERATING ROOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22881461 ↗
• MalfunctionJul 11, 2025Signal Artifact/Noise; Signal Artifact/Noise

  DURING THE PULSED FIELD ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH WORKMATE CLARIS AND A NON-ABBOTT (FARAWAVE) CATHETER, THE CLARIS WAS STARTED UP AS USUAL, AND WHEN APPLYING PULSE WITH THE FARAWAVE CATHETER, ¿NO SIGNAL¿ WAS DISPLAYED ON THE SCREEN AND THE WAVEFORM WAS NOT DISPLAYED FOR ABOUT 30 SECONDS TO 1 MINUTE, WHICH OCCURRED ABOUT 4 TIMES THROUGHOUT THE PROCEDURE. WAITING FOR THE WAVEFORM TO BE DISPLAYED OR POWER CYCLING THE AMPLIFIER AND DWS FOUR TIMES EACH RESOLVED THE ISSUE, BUT IT OCCURRED FREQUENTLY. IN ADDITION, THE CATHETER PINS WERE NOT CONNECTED DIRECTLY TO CLARIS CIM, BUT VIA THE NON-ABBOTT (CARTO PIU) SYSTEM. THE PROCEDURE WAS COMPLETED WITHOUT REPLACING THE CLARIS AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22480025 ↗
• MalfunctionJun 27, 2025Communication or Transmission Problem; Communication or Transmission Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THERE WAS A COMMUNICATION ISSUE WITH THE AMPLIFIER RESULTING IN A PROCEDURAL DELAY. THROUGHOUT THE PROCEDURE, AN ERROR MESSAGE "AMPLIFIER IS DISCONNECTED" DISPLAYED. THE MEDIA CONVERTER AND FIBER OPTIC CABLE WERE REPLACED. THE SYSTEM WAS NOT CONNECTED USING THE NETGEAR ETHERNET SWITCH, BUT THERE IS AN ISOLATOR CONNECTED TO THE ETHERNET CABLE. IT WAS ADVISED TO REMOVE THE ISOLATOR AND TRY TO USE WITHOUT IT. MULTIPLE SYSTEM REBOOTS RESOLVED THE ISSUE TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. THE AMPLIFIER HAS SINCE BEEN REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22351188 ↗
• MalfunctionJun 10, 2025Signal Artifact/Noise; Signal Artifact/Noise

  DURING AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA PROCEDURE, THERE WERE NO ECG SIGNALS VISIBLE AND THE PROCEDURE WAS CANCELLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22174828 ↗
• MalfunctionMay 30, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  DURING THE PROCEDURE, FLAT BLUE LINES WERE OBSERVED AFTER CONNECTING THE ECG LEADS TO THE PATIENT. THE AMPLIFIER WAS CONNECTED AND COMMUNICATING PERFECTLY. HOWEVER, THE PROCEDURE WAS POSTPONED TO THE NEXT DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22116235 ↗
• MalfunctionMay 22, 2025Communication or Transmission Problem; Communication or Transmission Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, A COMMUNICATION ISSUE OCCURRED CAUSING A DELAY. THE WORKMATE CLARIS AMPLIFIER WAS EXPERIENCING INTERMITTENT LOSS OF COMMUNICATION. ALL COMPONENTS WERE REPLACED EXCEPT FOR THE AMPLIFIER AND DWS. THE ISSUE WAS RESOLVED AFTER REBOOTING THE DWS AND AMPLIFIER 3 TIMES. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22073374 ↗
• MalfunctionMay 14, 2025Communication or Transmission Problem; Communication or Transmission Problem

  DURING THE PROCEDURE, A COMMUNICATION ISSUE OCCURRED CAUSING A PROCEDURE CANCELLATION. THE WORKMATE CLARIS AMPLIFIER DISCONNECTED. THE AMPLIFIER WAS STILL ON (GREEN LED LIT), THE FIBER OPTIC CABLE WAS WELL-INSERTED ALONG WITH THE RJ45 CABLE AND POWER CABLE INTO THE 12V POWER SUPPLY, AND THE MEDIA CONVERTER WAS ON AND FLASHING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22018870 ↗
• MalfunctionMay 5, 2025Failure to Power Up; Communication or Transmission Problem; Failure to Power Up; Communication or Transmission Problem

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, A COMMUNICATION ISSUE OCCURRED CAUSING A PROCEDURAL DELAY. THE AMPLIFIER DISCONNECTED AND DISPLAYED AN "AMPLIFIER ERROR" MESSAGE. A 20 MINUTE DELAY OCCURRED DUE TO TROUBLESHOOTING WHICH THE PHYSICIAN BELIEVES WAS CLINICALLY SIGNIFICANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21962017 ↗
• MalfunctionFeb 23, 2025Communication or Transmission Problem; Communication or Transmission Problem

  BEFORE AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA PROCEDURE, DURING PATIENT PREPARATION, IT WAS REPORTED THAT THE AMPLIFIER WAS NOT COMMUNICATING WITH THE PC RESULTING IN CANCELLATION OF THE PROCEDURE. RESTARTING THE SYSTEM TEMPORARILY RESOLVED THE ISSUE; HOWEVER, AFTER A FEW PACES, THE AMPLIFIER DISCONNECTED AGAIN, SHOWING THAT THE AMPLIFIER WAS OFF. RESTARTING MULTIPLE TIMES AND REPLACING THE FIBER OPTIC CABLE DID NOT RESOLVE THE ISSUE. EXCHANGING THE MEDIA CONVERTERS AND CABLES DID NOT RESOLVE THE ISSUE EITHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21442916 ↗
• MalfunctionJan 23, 2025Communication or Transmission Problem; Communication or Transmission Problem

  THE DEVICE WAS RECEIVED. FOLLOW UP REPORT NEEDED TO ADDRESS UPDATED ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21220158 ↗
• MalfunctionJan 8, 2025Communication or Transmission Problem; Communication or Transmission Problem

  DURING AN SVT ABLATION PROCEDURE, COMMUNICATION PROBLEMS CAUSED A DELAY. DURING AN SVT PROCEDURE, IT WAS NOTED THAT THE CONNECTION BETWEEN THE WORKMATE CLARIS AMPLIFIER AND THE WORKMATE CLARIS DWS WAS LOST, EVEN THOUGH THE CONNECTION WAS WORKING AT THE BEGINNING OF THE PROCEDURE. THE CONNECTIONS WERE CHECKED, THE POWER CABLES WERE RE-CONNECTED, AND THE CLEAR AMPLIFIER ERROR WAS ALSO ATTEMPTED, BUT THE ISSUE PERSISTED. THE SYSTEMS WERE TURNED OFF AND ON, AND AFTER THE RESTART THERE WAS A BRIEF MOMENT WHERE THE SIGNALS CAME BACK, BUT THEN THE CONNECTION WAS LOST AGAIN. IT WAS NOTED THAT THE EP-4 STIMULATOR TOUCHSCREEN WAS WORKING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY USING AN EXTERNAL PACEMAKER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FIELD SERVICE WAS LATER PERFORMED AT THE CUSTOMER SITE AND THE AMPLIFIER WAS REPLACED AT THAT TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21106437 ↗
• MalfunctionDec 2, 2024Failure to Power Up; Failure to Power Up

  DURING A PROCEDURE, THE AMPLIFIER WOULD NOT POWER UP RESULTING IN CANCELLATION OF THE PROCEDURE. THE AUDIBLE SIGNAL HAD NOT BEEN COMPLETED AND THE WORKMATE SYSTEM SHOWED THAT THE AMPLIFIER WAS DISCONNECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20824621 ↗
• MalfunctionNov 9, 2024Communication or Transmission Problem; Communication or Transmission Problem

  UPDATED EVENT DESCRIPTION: DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, COMMUNICATION ISSUES WITH THE AMPLIFIER RESULTED IN A PROCEDURAL DELAY. THE AMPLIFIER HAD LOST CONNECTION TO THE DWS DURING THE STUDY. THE AMPLIFIER WAS RESTARTED SEVERAL TIMES TO RESOLVE THE ISSUE AND COMPLETE THE PROCEDURE WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. SINCE THE EVENT, THERE HAVE BEEN NO ISSUES WITH THE AMPLIFIER, AND THE DEVICE HAS FUNCTIONED AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20647829 ↗
• MalfunctionOct 31, 2024Communication or Transmission Problem; Communication or Transmission Problem

  DURING MULTIPLE PROCEDURES, THERE WERE ISSUES WITH THE WORKMATE CLARIS AMPLIFIER DISCONNECTING, RESULTING IN A PROCEDURAL DELAY. THE MEDIA CONVERTER WAS EXCHANGED BUT THE AMPLIFIER WOULD STILL GO OFFLINE INTERMITTENTLY. THE PROCEDURES WERE COMPLETED SUCCESSFULLY BUT WITH DELAYS CAUSED BY HAVING TO REBOOT THE AMPLIFIER EVERY TIME THE ISSUE OCCURRED. THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20578546 ↗
• MalfunctionSep 9, 2024Signal Artifact/Noise; Signal Artifact/Noise

  DURING PATIENT PREPARATION WITH THE PATIENT IN THE ROOM, NO ECGS WERE NOTED ON THE SCREEN, ONLY FLAT BLUE LINES WERE VISIBLE EVEN AFTER AMPLIFIER WAS SHOWING CONNECTED. AFTER MULTIPLE RESTARTS AND CHANGING THE POWER SOURCE, THE ISSUE REMAINED AND THE CASE WAS CANCELLED. THE PROCEDURE HAD TO BE POSTPONED TO THE NEXT DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20171968 ↗
• MalfunctionSep 4, 2024Communication or Transmission Problem; Communication or Transmission Problem

  DURING DEVICE PREPARATION FOR AN ATRIAL FIBRILLATION PROCEDURE, A COMMUNICATION ISSUE OCCURRED CAUSING A DELAY. WHILE THE PATIENT WAS ON THE TABLE, THE WORKMATE AMPLIFIER CONNECTED ON START-UP BUT DISCONNECTED AFTER APPROXIMATELY 10 MINUTES. THE AMPLIFIER WAS RESTARTED, BUT THE SAME ISSUE OCCURRED. THE MEDIA CONVERTER AND FIBER OPTIC CABLE WERE REPLACED WHICH DID NOT RESOLVE THE ISSUE. THE AMPLIFIER THEN RECONNECTED ON ITS OWN. TROUBLESHOOTING DELAYED THE START OF THE PROCEDURE BY ONE HOUR. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20134523 ↗
• MalfunctionAug 22, 2024Communication or Transmission Problem; Communication or Transmission Problem

  DURING A WOLFF-PARKINSON-WHITE PROCEDURE, THE AMPLIFIER AND MEDIA CONVERTER WERE HAVING COMMUNICATION ISSUES THAT RESULTED IN A CANCELLATION OF PROCEDURE. AFTER THE PATIENT WAS CONNECTED TO THE WORKMATE CLARIS ECG, BUT BEFORE VEIN PUNCTURE, A 12 LEAD ECG HAD A SLOW DRAWING SPEED ON THE LIVE SCREEN OF THE WORKMATE CLARIS SYSTEM. THE 200MM/SEC LOOKED LIKE 50MM/SEC. THE DRAWING SPEED WAS ABLE TO BE MANUALLY CHANGED, BUT STILL APPEARED SLOWER THAN USUAL. THE 400MM/SEC LOOKED LIKE NORMAL SPEED. ADDITIONALLY, THE R-R INTERVAL DEFINED DURING SETUP MEASURED EVERY QRS AS IT SHOULD, BUT THE INTERVAL WAS SHORTER (ABOUT 250MS =240BPM) THAN THE PATIENT¿S ACTUAL HEART RATE 80BPM (ABOUT 750MS). THE HEART RATE WAS ALSO BEING MEASURED ON THE NON-ABBOTT (PHILLIPS) MONITOR. CHANGING THE SPEED DID NOT AFFECT THE R-R INTERVAL. CHANGING THE CATHMAPS OR LEADS WHERE THE R-R INTERVAL WAS MEASURED DID NOT RESOLVE THE ISSUE. RESTARTING THE SYSTEM MULTIPLE TIMES AND CHECKING ALL SETTINGS, INCLUDING THE INI SETTINGS FILE, DID NOT RESOLVE THE ISSUE. THE WORKMATE CLARIS CPU IS Z440 AND CLARIS SW VERSION IS 1.3.1. THE SITE HAD SPARE CPU Z440 WITH CLARIS SW VERSION 1.1.1, WHICH WAS SWAPPED TO SEE WHETHER THE ISSUE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20036727 ↗
• MalfunctionAug 20, 2024Signal Artifact/Noise; Signal Artifact/Noise

  DURING THE SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, SIGNAL ISSUES RESULTED IN THE PROCEDURE BEING CANCELLED. IT WAS OBSERVED THAT THE ECGS WERE NOT DISPLAYED EVEN WHEN THE AMPLIFIER CONNECTION WAS ESTABLISHED. THE AMPLIFIER WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED THE NEXT DAY WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20007995 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K132073, K210392. One submission often covers many models, so check the product and lot details in each record.

• Z-1853-2021 · May 5, 2021 · Terminated
  v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model H700123. The WorkMate Claris" System is a computer-based electrocardiographic recording and monitorin
• Z-1855-2021 · May 5, 2021 · Terminated
  WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012
• Z-1854-2021 · May 5, 2021 · Terminated
  v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris" System Display, Model H700124, The WorkMate Claris" System is a computer-based electrocardiographic recording an