WorkMate Claris™ H700124Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 05415067001245), received between Apr 19, 2019 and Sep 16, 2024 — classified as 7 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Unexpected Shutdown” (9 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2024Communication or Transmission Problem; Communication or Transmission Problem

  THIS REPORT INCLUDES UPDATED DEVICE INFORMATION. RELATED MANUFACTURER REFERENCE: 2184149-2024-00175.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20226312 ↗
• MalfunctionJun 24, 2022Failure of Device to Self-Test; Failure of Device to Self-Test

  WHEN PREPARING FOR THE PROCEDURE, THE EP-4 WAS OFF AND SELF TEST FAILED WHICH RESULTED IN THE CANCELLATION OF THE PROCEDURE AS THE TROUBLESHOOTING DID NOT RESOLVE THE ISSUE. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14802024 ↗
• MalfunctionNov 16, 2021Output Problem; Output Problem

  DURING THE PROCEDURE, THE STIMULATOR WAS UNABLE TO PACE FROM ANY CHANNEL, BUT EMERGENCY PACING WAS STILL FUNCTIONAL. ALL CONNECTIONS WERE CHECKED AND THE SYSTEM PASSED THE SELF-TEST, HOWEVER, NO STIMULATION OR IMPEDANCE WAS ABLE TO BE PERFORMED. THE CHANNEL BOXES WERE CHECKED AND THE SYSTEM WAS REBOOTED IN THE CORRECT SEQUENCE WITH NO RESOLUTION. THE PROCEDURE WAS UNABLE TO BE COMPLETED DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12821377 ↗
• MalfunctionJul 30, 2021Communication or Transmission Problem; Communication or Transmission Problem

  DURING AN ATRIAL FLUTTER ABLATION PROCEDURE, WORKMATE CLARIS STIMULATOR WAS UNABLE TO COMMUNICATE. THE MAIN FRAME WAS REPLACED TO RESOLVE THE ISSUE. THE PROCEDURE WAS CANCELLED AND THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12252297 ↗
• MalfunctionJun 9, 2021Signal Artifact/Noise; Signal Artifact/Noise

  DURING A PREMATURE VENTRICULAR CONTRACTIONS ABLATION PROCEDURE, THERE WAS ARTIFACT WHILE PACING THAT LED TO A PROLONGED PROCEDURE. THE SURFACE SIGNALS WERE ENLARGED AND COULD NOT BE DISTINGUISHED. THE SYSTEM WAS REBOOTED TWICE AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11967472 ↗
• MalfunctionMay 21, 2021Unexpected Shutdown; Unexpected Shutdown

  DURING AN ATRIAL FLUTTER ABLATION PROCEDURE, THE WORKMATE CLARIS WOULD KEEP ON STARTING A NEW CASE AND RESTARTING THE LOG WHICH RESULTED IN A PROLONGED PROCEDURE. MULTIPLE TROUBLESHOOTING EFFORTS WERE ATTEMPTED, BUT THE ISSUES REMAINED. ALTHOUGH THE PATIENT EXPERIENCED A PROLONGED PROCEDURE WITH EXTENDED SEDATION, THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND THE PROCEDURE WAS STILL COMPLETED. FURTHER TROUBLESHOOTING AT A LATER TIME WAS ABLE TO RESOLVE THE ISSUES AND THE SYSTEM IS FUNCTIONING AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11862746 ↗
• MalfunctionMay 21, 2021Unexpected Shutdown; Unexpected Shutdown

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, THE WORKMATE CLARIS WOULD KEEP ON STARTING A NEW CASE AND RESTARTING THE LOG WHICH RESULTED IN A PROLONGED PROCEDURE. MULTIPLE TROUBLESHOOTING EFFORTS WERE ATTEMPTED, BUT THE ISSUES REMAINED. ALTHOUGH THE PATIENT EXPERIENCED A PROLONGED PROCEDURE WITH EXTENDED SEDATION, THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND THE PROCEDURE WAS STILL COMPLETED. FURTHER TROUBLESHOOTING AT A LATER TIME WAS ABLE TO RESOLVE THE ISSUES AND THE SYSTEM IS FUNCTIONING AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11862740 ↗
• MalfunctionMay 21, 2021Unexpected Shutdown; Unexpected Shutdown

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, THE WORKMATE CLARIS WOULD KEEP ON STARTING A NEW CASE AND RESTARTING THE LOG WHICH RESULTED IN A PROLONGED PROCEDURE. MULTIPLE TROUBLESHOOTING EFFORTS WERE ATTEMPTED, BUT THE ISSUES REMAINED. ALTHOUGH THE PATIENT EXPERIENCED A PROLONGED PROCEDURE WITH EXTENDED SEDATION, THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND THE PROCEDURE WAS STILL COMPLETED. FURTHER TROUBLESHOOTING AT A LATER TIME WAS ABLE TO RESOLVE THE ISSUES AND THE SYSTEM IS FUNCTIONING AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11862729 ↗
• MalfunctionMay 21, 2021Unexpected Shutdown; Unexpected Shutdown

  DURING A SUPRAVENTRICULAR TACHYCARDIA ABLATION PROCEDURE, THE WORKMATE CLARIS WOULD KEEP ON STARTING A NEW CASE AND RESTARTING THE LOG WHICH RESULTED IN A PROLONGED PROCEDURE. MULTIPLE TROUBLESHOOTING EFFORTS WERE ATTEMPTED, BUT THE ISSUES REMAINED. ALTHOUGH THE PATIENT EXPERIENCED A PROLONGED PROCEDURE WITH EXTENDED SEDATION, THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND THE PROCEDURE WAS STILL COMPLETED. FURTHER TROUBLESHOOTING AT A LATER TIME WAS ABLE TO RESOLVE THE ISSUES AND THE SYSTEM IS FUNCTIONING AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11862728 ↗
• MalfunctionMay 21, 2021Unexpected Shutdown; Unexpected Shutdown

  DURING A SUPRAVENTRICULAR TACHYCARDIA ABLATION PROCEDURE, THE WORKMATE CLARIS WOULD KEEP ON STARTING A NEW CASE AND RESTARTING THE LOG WHICH RESULTED IN A PROLONGED PROCEDURE. MULTIPLE TROUBLESHOOTING EFFORTS WERE ATTEMPTED, BUT THE ISSUES REMAINED. ALTHOUGH THE PATIENT EXPERIENCED A PROLONGED PROCEDURE WITH EXTENDED SEDATION, THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND THE PROCEDURE WAS STILL COMPLETED. FURTHER TROUBLESHOOTING AT A LATER TIME WAS ABLE TO RESOLVE THE ISSUES AND THE SYSTEM IS FUNCTIONING AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11862650 ↗
• MalfunctionMay 21, 2021Unexpected Shutdown; Unexpected Shutdown

  DURING A SUPRAVENTRICULAR TACHYCARDIA ABLATION PROCEDURE, THE WORKMATE CLARIS WOULD KEEP ON STARTING A NEW CASE AND RESTARTING THE LOG WHICH RESULTED IN A PROLONGED PROCEDURE. MULTIPLE TROUBLESHOOTING EFFORTS WERE ATTEMPTED, BUT THE ISSUES REMAINED. ALTHOUGH THE PATIENT EXPERIENCED A PROLONGED PROCEDURE WITH EXTENDED SEDATION, THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND THE PROCEDURE WAS STILL COMPLETED. FURTHER TROUBLESHOOTING AT A LATER TIME WAS ABLE TO RESOLVE THE ISSUES AND THE SYSTEM IS FUNCTIONING AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11862415 ↗
• MalfunctionMay 21, 2021Unexpected Shutdown; Unexpected Shutdown

  DURING THE PROCEDURE, THE WORKMATE (B)(6) WOULD KEEP ON STARTING A NEW CASE AND RESTARTING THE LOG WHICH RESULTED IN A CANCELLED PROCEDURE. MULTIPLE TROUBLESHOOTING EFFORTS WERE ATTEMPTED, BUT THE ISSUES REMAINED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER TROUBLESHOOTING AT A LATER TIME WAS ABLE TO RESOLVE THE ISSUES AND THE SYSTEM IS FUNCTIONING AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11862363 ↗
• MalfunctionMay 21, 2021Unexpected Shutdown; Unexpected Shutdown

  DURING THE PROCEDURE, THE WORKMATE CLARIS WOULD KEEP ON STARTING A NEW CASE AND RESTARTING THE LOG WHICH RESULTED IN A CANCELLED PROCEDURE. MULTIPLE TROUBLESHOOTING EFFORTS WERE ATTEMPTED, BUT THE ISSUES REMAINED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER TROUBLESHOOTING AT A LATER TIME WAS ABLE TO RESOLVE THE ISSUES AND THE SYSTEM IS FUNCTIONING AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11862320 ↗
• MalfunctionMay 20, 2021Application Program Version or Upgrade Problem; Unexpected Shutdown; Application Program Version or Upgrade Problem; Unexpected Shutdown

  DURING THE PROCEDURE, THE CLARIS SYSTEM UNEXPECTEDLY SHUT DOWN. THE SYSTEM WAS RESTARTED AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11855224 ↗
• MalfunctionMay 19, 2021No Display/Image; Application Program Version or Upgrade Problem; No Display/Image; Application Program Version or Upgrade Problem

  DURING THE PROCEDURE, THE SCREEN WENT BLACK. THE SYSTEM WAS REBOOTED AND THE APPLICATION DISPLAYED PROPERLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11850568 ↗
• MalfunctionMar 17, 2021Communication or Transmission Problem; Communication or Transmission Problem

  DURING THE PROCEDURE, THERE WAS NO SENSE INTERVAL AND NO SYNC SIGNAL AND THE CASE WAS CANCELLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11507986 ↗
• InjuryFeb 11, 2021Signal Artifact/Noise; Signal Artifact/Noise

  DURING A VENTRICULAR EXTRA-SYSTOLE ABLATION PROCEDURE, SIGNAL ARTIFACT WAS NOTED ON THE ELECTROCARDIOGRAM WHEN ABLATIONS WERE DELIVERED WHICH RESULTED IN A RIGHT BUNDLE BRANCH BLOCK. WHEN ABLATION WAS PERFORMED NEAR THE BUNDLE OF HIS, A RIGHT BUNDLE BRANCH BLOCK WAS FOUND AFTERWARDS AND THE PROCEDURE WAS CANCELLED. NO INTERVENTION WAS PERFORMED ON THE PATIENT. THE ELECTRODES WERE NOTED TO HAVE BEEN APPLIED PROPERLY.

  Patient problems: Heart Block

  MAUDE report 11314833 ↗
• MalfunctionFeb 10, 2021Communication or Transmission Problem; Communication or Transmission Problem

  WHEN ATTEMPTING TO PERFORM HIS SYNC ON VENTRICULAR PREMATURE BEATS, THE SYNCHRONIZATION ON THE SYSTEM WOULD NOT WORK AND CAUSED A DELAY. AN INCORRECT INTERVAL READING, AND ERROR MESSAGE WERE NOTED, AND THE CASE WAS DELAYED BY APPROXIMATELY ONE HOUR. HOWEVER, THE CASE WAS COMPLETED SUCCESSFULLY WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11308541 ↗
• InjuryDec 7, 2020Communication or Transmission Problem; Communication or Transmission Problem

  DURING THE PROCEDURE, A COMMUNICATION ISSUE WAS NOTED AND THE PROCEDURE WAS CANCELLED. THE CLARIS SYSTEM DID NOT RECOGNIZE THE STIMULATOR AND INDICATED THAT IT WAS NOT CONNECTED ON THE CLARIS "STIM" MENU. THE ISSUE COULD NOT BE RESOLVED AND THE PROCEDURE WAS ABANDONED AND RESCHEDULED FOR ANOTHER DAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10959779 ↗
• InjuryOct 14, 2020Failure to Analyze Signal; Failure to Analyze Signal

  DURING THE PROCEDURE, THERE WERE NO SIGNALS VISIBLE ON THE SYSTEM AND THE CASE WAS ABANDONED. THERE WERE NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10678785 ↗
• InjuryMar 16, 2020Signal Artifact/Noise; Signal Artifact/Noise

  DURING THE PROCEDURE NOISE WAS EXPERIENCED ON THE SURFACE SIGNALS WHILE PACING AND A CLINICALLY SIGNIFICANT DELAY OCCURRED. WHEN THE PHYSICIAN ABLATED THE SLOW PATHWAY AREA FOR TREATMENT OF THE AVNRT, CS PACING AT 500 MS WAS REQUESTED TO WATCH FOR THE AV NODE CONDUCTION. WITH THE PRESENCE OF THE HIGH AMPLITUDE PACING ARTIFACT ON SURFACE EGMS DURING THIS CASE, THERE WERE LARGE AMPLITUDE SURFACE ELECTROGRAMS TIMED WITH BOTH THE PACING SPIKE AND THE QRS. RF ENERGY WAS APPLIED TO THE ABLATION CATHETER IN THE SLOW PATHWAY AREA. DURING THE FIRST ABLATION, THE AV NODAL CONDUCTION TIME WAS AFFECTED. THE PHYSICIAN STOPPED RF ABLATION WITHIN 1.2 SECONDS OF NOTICING THE CONDUCTION DELAY. AV WENCKEBACH WAS TESTED WITH CS PACING AND FOUND TO BE 490 MS, WHICH WAS 150 MS LONGER THAN HAD BEEN MEASURED AT BASELINE. AT THIS POINT THE PHYSICIAN DECIDED TO WAIT FOR AT LEAST 30 MINUTES TO SEE IF THE AV NODAL CONDUCTION TIME WOULD RECOVER TO BASELINE MEASUREMENTS BEFORE DECIDING HOW TO PROCEED. AV WENCKBACHE WAS TESTED CONTINUALLY DURING THIS PERIOD AT 5-10 MINUTE INTERVALS. AFTER 30 MINUTES OR MORE, THE PHYSICIAN DECIDED TO ADMINISTER ISOPROTERENOL. SINUS RATE INCREASED AND AV CONDUCTION TIME DECREASED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9835157 ↗
• InjuryDec 18, 2019Failure to Analyze Signal; Failure to Analyze Signal

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A CANCELLATION OCCURRED DUE TO INTRACARDIAC SIGNAL LOSS. TROUBLESHOOTING CONSISTED OF BYPASSING CARDO, POWER CYCLING, SWAPPING THE ECG CABLES, CHECKING THE CONNECTION BETWEEN THE STIMULATOR AND AMPLIFIER, REPOSITIONING THE RIGHT LEAD, EXCHANGING THE RIGHT LEG LEAD PATCH AND RESETTING THE NOTCH FILTER BUT THE ISSUE REMAINED. THE PROCEDURE WAS CANCELLED AND THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9491397 ↗
• MalfunctionNov 27, 2019Failure to Power Up; Failure to Power Up

  DURING A POWER OUTAGE, THE CPU WOULD NOT BOOT BACK INTO THE PROGRAM, DESPITE SEVERAL POWER CYCLING ATTEMPTS. THE PROCEDURE WAS BEYOND THE THERAPY STAGE SO NO ADDITIONAL RECORDING OR ABLATION WAS DONE AFTER THIS EVENT. THE CASE WAS ENDED AND THE PATIENT WAS DISCHARGED IN STABLE CONDITION. THE PATIENT NEEDED TO BE RESCHEDULED FOR A SECOND PART OF THE PROCEDURE WHICH WAS NOT ATTEMPTED AFTER THE SYSTEM WENT DOWN.THE SYSTEM WAS REBOOTED AND EVENTUALLY CAME BACK ONLINE. A UPS WAS INSTALLED TO RESOLVE THE ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9382901 ↗
• InjuryOct 24, 2019Communication or Transmission Problem; Communication or Transmission Problem

  DURING THE PROCEDURE, SIGNAL AND COMMUNICATION ISSUES OCCURRED AND THE CASE WAS CANCELLED. THERE WERE NO ECG SIGNALS AND NO COMMUNICATION FROM THE AMPLIFIER TO THE CLARIS SYSTEM. ALL CONNECTIONS WERE CHECKED AND ALL SYSTEMS WERE POWER CYCLED. TESTS WERE RUN ON THE AMPLIFIER WHICH CONFIRMED IT WOULD NOT COMMUNICATE. UPON STARTING THE AMPLIFIER, THE USUAL 3 BEEPS WERE NOT HEARD. THE AMPLIFIER WAS POWER CYCLED AND TESTED TWICE WHICH DID NOT RESOLVE THE ISSUE. THE CASE WAS CANCELLED WITH NO CONSEQUENCES TO THE PATIENT. THE PROCEDURE HAS BEEN RESCHEDULED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9235125 ↗
• InjurySep 20, 2019Tactile Prompts/Feedback; Tactile Prompts/Feedback

  DURING THE PROCEDURE, ATRIAL FIBRILLATION WAS INDUCED DUE TO A LOSS OF PACING CONTROL. THE MOUSE POINTER ON BOTH THE ODYSSEY LARGE MONITOR AND NATIVE CLARIS MONITOR WAS SLOW TO REACT AND MOVEMENT WAS INTERMITTENT. DURING NORMAL PACING MANEUVERS, CONTROL OF THE PACING WAS LOST. THERE WAS DECREASE IN CL DOWN TO 100 MS. IT WAS NOT POSSIBLE TO STOP OR ADJUST THE PACING WITH EP-4 TOUCH SCREEN OR THE CLARIS OR ODYSSEY MOUSE OR KEYBOARD CONTROLS. AFTER SEVERAL ATTEMPTS THE PACING WAS STOPPED. THE SYSTEM AND TOUCH SCREEN WERE REBOOTED AND THE PROCEDURE CONTINUED. AFTER A WHILE THE ISSUE RECURRED. THE SYSTEM AND TOUCH SCREEN WERE REBOOTED AGAIN AND THE PROCEDURE CONTINUED. ATRIAL FIBRILLATION WAS INDUCED. THERE WAS A SPONTANEOUS RECOVERY TO SINUS RHYTHM AND NO CARDIOVERSION WAS NEEDED. THE PROCEDURE WAS COMPLETED WITHOUT ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: Atrial Fibrillation

  MAUDE report 9097467 ↗

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-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
• 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