WorkMate ClarisRecalls & reported problems across all models

We found 8 models of WorkMate Claris by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 196 adverse event reports in the FDA's MAUDE database, received between Jul 11, 2018 and Aug 19, 2026 — classified as 61 injuries, 135 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (101 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 WorkMate Claris problems

WorkMate Claris models

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

• WorkMate Claris™ H700150

  COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  72 reports
• WorkMate Claris™ H700977

  COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  45 reports
• WorkMate Claris™ H700169

  Computer, diagnostic, programmable
  37 reports
• WorkMate Claris™ H700124

  COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  26 reports
• WorkMate Claris™ H700123

  COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  12 reports
• WorkMate Claris™ H701703

  COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  2 reports
• WorkMate Claris™ H700131

  COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  1 report
• WorkMate Claris™ H701806

  Generator, pulse, pacemaker, external programmable (for electrophysiological studies only)
  1 report

Recent WorkMate Claris adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionFeb 27, 2026Communication or Transmission Problem

  DURING AN ABLATION PROCEDURE, THE AMPLIFIER DISPLAYED AN ERROR MESSAGE INDICATING THAT THE AMPLIFIER WAS DISCONNECTED. AFTER RESTARTING THE SYSTEM, THE MESSAGE CHANGED TO ¿AMPLIFIER CONNECTED,¿ HOWEVER NO ECG SIGNALS WERE DISPLAYED. THE ECG CABLE WAS REPLACED, BUT THE ISSUE PERSISTED. DUE TO THE ISSUE, THE ABLATION PROCEDURE WAS CANCELLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470404 ↗
• MalfunctionFeb 26, 2026Connection Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE USING NON-ABBOTT PFA (FARAWAVE), THE PROCEDURE WAS ABANDONED DUE TO CONNECTION AND PACING ISSUES. IT WAS NOTED THAT THERE WERE COMMUNICATION ISSUES WITH THE EP-4 TOUCHSCREEN AND THE WORKMATE CLARIS COMPUTER AND PACING WAS UNABLE TO BE COMPLETED. A "CHECK OUTPUT SWITCHES/CABLES" MESSAGE APPEARED. THE CABLES WERE RECONNECTED AND EXCHANGED, AND THE EP-4 CARDIAC STIMULATOR WAS REPLACED, BUT THE ISSUES PERSISTED. IT WAS VERIFIED THAT CABLES WERE CONNECTED, THE CHANNELS WERE TURNED OFF AND ON BOTH PHYSICALLY AND ON THE GUI. THE PROCEDURE WAS UNABLE TO BE COMPLETED SUCCESSFULLY. DURING FURTHER TROUBLESHOOTING, IT WAS OBSERVED THAT THE STIM PORT ON THE WORKMATE CLARIS COMPUTER HAD COLLAPSED AND THIS DAMAGE WAS PREVENTING THE EP-4 TOUCHSCREEN FROM CONNECTING TO THE DEVICE. THE EP-4 HAS NOT BEEN ABLE TO PROPERLY PACE SINCE. IT IS ALLEGED THAT BOTH THE EP-4 AND WORKMATE CLARIS COMPUTER CONTRIBUTED TO THE CANCELATION OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24462331 ↗
• MalfunctionJan 27, 2026Communication or Transmission Problem

  THE ATRIAL FIBRILLATION PROCEDURE WITH RADIOFREQUENCY ABLATION WAS CANCELED. DURING THE PROCEDURE, THERE WAS NO COMMUNICATION BETWEEN THE WORKMATE CLARIS AMPLIFIER AND THE CPU. TROUBLESHOOTING INCLUDED SEVERAL RESTARTS OF THE AMPLIFIER, THE CPU, AND THE POWER SUPPLIES OF THE ETHERNET CONVERTER AND THE AMPLIFIER CART WITH NO RESOLUTION. THE POWER CABLES WERE CHECKED AND THE FIBER OPTIC CABLE WAS CHANGED WITH NO RESOLUTION. THE PROCEDURE WAS CANCELED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24188416 ↗
• 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 ↗
• MalfunctionJan 15, 2026Unexpected Shutdown

  DURING A PROCEDURE, ELECTRICAL ISSUES RESULTED IN THE PROCEDURE BEING CANCELLED. IT WAS NOTED THAT THE WORKMATE CLARIS COMPUTER WAS REPEATEDLY POWERING DOWN AND BOOTING UP BY ITSELF. THE PROCEDURE WAS ABANDONED AND THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24079011 ↗
• MalfunctionNov 29, 2025No Display/Image; No Display/Image

  AFTER PREPPING THE PATIENT FOR AN ATRIAL FIBRILLATION PROCEDURE, IT WAS NOTED THAT THE WORKMATE CLARIS MONITORS OF THE 48¿¿ TABLE WERE NOT SHOWING ANY SIGNAL. REMOTE TROUBLESHOOTING WAS DONE, BUT THE ISSUE PERSISTED. THE PROCEDURE WAS CANCELLED. THE ISSUE WAS RESOLVED ON A DIFFERENT DAY BY REPLACING THE WORKMATE COMPUTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23675614 ↗
• MalfunctionNov 24, 2025Output Problem; Output Problem

  DURING THE AV NODE ABLATION PROCEDURE, OUTPUT ISSUES WITH THE COMPUTER RESULTED IN THE PROCEDURE BEING CANCELLED. WHEN STARTING THE SYSTEM, THE WORKMATE CLARIS CPU SHOWED AN ERROR MESSAGE "942-MEMORY TRAINING ERROR." THE DIMM 1 ON THE CPU EXPERIENCED AN ERROR DURING TRAINING (CODE 1501). THE COMPUTER WAS SHUT DOWN AND POWERED ON SEVERAL TIMES, DISCONNECTED FROM THE POWER SOURCE, CONNECTED AGAIN AND POWERED ON, BUT THE ERROR MESSAGE PERSISTED. THE PROCEDURE WAS CANCELLED AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23640656 ↗
• 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 ↗
• MalfunctionAug 13, 2025Communication or Transmission Problem; Communication or Transmission Problem

  DURING AN EP/V STIM STUDY PROCEDURE, A COMMUNICATION ISSUE OCCURRED AND THE PROCEDURE WAS CANCELLED. THERE WERE NO SIGNALS AND A ¿CHECK CONNECTIONS¿ ERROR MESSAGE WAS NOTED. RE-BOOTING MULTIPLE TIMES DID NOT RESOLVE THE ISSUE. THE FIBER OPTIC CABLE, MEDIA CONVERTER, AND ETHERNET CABLE WERE REPLACED WITH NO RESOLUTION AND THE AMPLIFIER WAS SUSPECTED AS THE ISSUE. THE ISSUE WAS IDENTIFIED WHILE THE PATIENT WAS ON THE TABLE BEING SET UP AND MULTIPLE ATTEMPTS WERE MADE TO CORRECT THE CONNECTION ISSUE WITHOUT SUCCESS. THE PHYSICIAN DID PLACE ONE CATHETER TO ATTEMPT STIMMING MANEUVER BUT ULTIMATELY DECIDED TO ABORT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22792643 ↗

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