WorkMate Claris™ H700977Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 05415067009777), received between Jul 11, 2018 and Feb 26, 2026 — classified as 12 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (12 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 45 reports, in the reporter's own words as published by the FDA.

• 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 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 ↗
• MalfunctionJun 20, 2025Failure to Power Up; Failure to Power Up

  DURING AN AVNRT PROCEDURE, ELECTRICAL ISSUES RESULTED IN THE PROCEDURE BEING CANCELLED. IT WAS NOTED THAT THE COMPUTER WOULD NOT BOOT UP, BELIEVED TO BE RELATED TO A BITLOCKER ISSUE. NO ENCRYPTION KEY WAS AVAILABLE UNTIL THE FOLLOWING DAY SO THE PROCEDURE WAS POSTPONED. THE COMPUTER WAS REPLACED WHICH RESOLVED THE ISSUE 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 22301615 ↗
• MalfunctionDec 3, 2024Output Problem; Output Problem

  DURING A WOLFF-PARKINSON-WHITE PROCEDURE, A PHYSICAL MEMORY ERROR OCCURRED ON THE WORKMATE COMPUTER RESULTING IN CANCELLATION OF THE PROCEDURE. DUE TO THE ERROR, THE WORKMATE COMPUTER WOULD NOT POWER UP AND ABLATION COULD NOT BE PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20839720 ↗
• MalfunctionOct 8, 2024Communication or Transmission Problem; Output Problem; Communication or Transmission Problem; Output Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE COMPUTER WAS HAVING COMMUNICATION AND OUTPUT ISSUES WHICH RESULTED IN A CANCELLATION OF PROCEDURE. WHILE PATIENT WAS ON THE TABLE, AN "AMPLIFIER IS DISCONNECTED" MESSAGE AND "UNABLE TO OPEN PORT 44.44.44.90" MESSAGE APPEARED. THE FIBER OPTIC CABLE, MEDIA CONVERTER, AND AMPLIFIER WERE ALL SWAPPED OUT, BUT WITH NO RESOLUTION. THE COMPUTER WAS REPLACED, AND THE ISSUE WAS RESOLVED. HOWEVER, DUE TO HOW LONG TROUBLESHOOTING TOOK, THE PROCEDURE WAS ABORTED AND RESCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20396731 ↗
• MalfunctionAug 15, 2024Failure to Power Up; Failure to Power Up

  DURING PATIENT PREPARATION FOR AN ATRIAL FIBRILLATION PROCEDURE, THE CLARIS DWS WAS BLINKING RED AND WOULD NOT BOOT UP WHICH CAUSED A DELAY. A CLARIS DWS FROM ANOTHER ROOM WAS OBTAINED WHICH RESOLVED THE ISSUE WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19991353 ↗
• MalfunctionJul 24, 2024Signal Artifact/Noise; Signal Artifact/Noise

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, A NOISE ARTIFACT RESULTED IN THE CANCELLATION OF THE PROCEDURE. DURING THE PROCEDURE, IT WAS REPORTED THE WORKMATE CLARIS COMPUTER WOULD NOT SHOW ANY SIGNALS. IT HAD BLUE OVER-SATURATED SIGNALS ON THE EGM. MOVING THE EGM PORTS DID NOT RESOLVE THE ISSUE. THE PACING CHANNELS BROUGHT THE SIGNALS BACK TO UNSATURATED, BUT THIS WAS COMPLETED AFTER THE CASE WAS ABANDONED. THE ECG SIGNALS APPEARED AS THEY SHOULD DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19819745 ↗
• MalfunctionJul 1, 2024Communication or Transmission Problem; Communication or Transmission Problem

  DURING PREPARATION FOR AN AV NODE PROCEDURE WITH A PERMANENT PACEMAKER IMPLANT, WITH THE PATIENT IN THE ROOM, THERE WAS A COMMUNICATION ISSUE WITH THE WORKMATE COMPUTER RESULTING IN CANCELLATION OF THE PROCEDURE. THE WORKMATE COMPUTER WAS NOT COMMUNICATING WITH THE AMPLIFIER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19652426 ↗
• MalfunctionDec 5, 2023Communication or Transmission Problem; Communication or Transmission Problem

  WHEN STARTING THE EQUIPMENT, WITH THE PATIENT IN THE ROOM, THERE WERE COMMUNICATION ISSUES RESULTING IN CANCELLATION OF THE PROCEDURE. FIRST THE WORKMATE CLARIS AMPLIFIER DISCONNECTED, THEN SHORTLY AFTER AN EP-4 OFF OR NOT CONNECTED ERROR SHOWED ON THE WORKMATE CLARIS DISPLAY WORKSTATION REVIEW SCREEN. THE EP-4 TOUCHSCREEN WAS ON AND FUNCTIONING, SO THE WORKMATE CLARIS SYSTEM WAS RESTARTED. THE WORKMATE CLARIS AMPLIFIER TURNED ON, BUT THE EP-4 STIMULATOR REMAINED DISCONNECTED. AFTER A FEW MINUTES THE WORKMATE CLARIS AMPLIFIER LOST CONNECTION ONCE AGAIN AND THE PROCEDURE WAS POSTPONED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18268932 ↗
• MalfunctionNov 1, 2023Communication or Transmission Problem; Communication or Transmission Problem

  DURING PREP WITH THE PATIENT ON THE TABLE, A COMMUNICATION ISSUE OCCURRED AND THE PROCEDURE WAS CANCELLED. THE MEDIA CONVERTER, POWER SUPPLY FOR THE MEDIA CONVERTER, FIBER AND ETHERNET CABLES WERE EXCHANGED AND THE ISSUE REMAINED. THE AMPLIFIER WAS THEN DISCONNECTED 3 TIMES WHICH DID NOT RESOLVE THE ISSUE AND THE PROCEDURE WAS CANCELLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18048329 ↗
• MalfunctionSep 13, 2023Failure to Power Up; Failure to Power Up

  DURING THE PROCEDURE WITH THE PATIENT PREPPED, THE WORKMATE CLARIS DISPLAY WORKSTATION CONTINUOUSLY BOOTED UP AND THE CASE WAS ABANDONED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17737147 ↗
• MalfunctionAug 31, 2023Unexpected Shutdown; Unexpected Shutdown

  DURING THE RADIO FREQUENCY ABLATION PROCEDURE, UNEXPECTED SHUT OFF ISSUES OCCURRED. THE POWER CYCLE WAS RETRIED BUT WITH NO RESOLUTION, THE SOFTWARE WAS NOT BOOTING UP AND THE CASE WAS ABANDONED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17662969 ↗
• MalfunctionDec 14, 2022Unexpected Shutdown; Unexpected Shutdown

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE CLARIS CPU EXPERIENCED A HARD SHUT DOWN TOWARDS THE END OF THE PROCEDURE, BEFORE PERFORMING FINAL TESTING. THE SYSTEM WAS ABLE TO FULLY POWER ON AND RESTORE CASE RECORDS BY UNPLUGGING THE POWER FROM THE MAIN CPU AS WELL AS FROM THE BATTERY PACK/SURGE PROTECTOR THAT IT IS PLUGGED INTO. THERE WAS NO APPARENT PHYSICAL CONTACT MADE TO INITIATE THE SHUTDOWN. THE REMAINDER OF THE PROCEDURE WAS CANCELLED, LEAVING THE LAST PART OF THE EP STUDY (PACE TESTING) UNFINISHED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15976471 ↗
• MalfunctionNov 30, 2022Power Problem; Power Problem

  DURING DEVICE PREPARATION FOR AN ATYPICAL ATRIAL FLUTTER PROCEDURE AFTER THE PATIENT WAS PREPPED, THERE WAS A POWER ISSUE RESULTING IN CANCELLATION OF THE PROCEDURE WITH NO ADVERSE CONSEQUENCES. AFTER TURNING ON THE WORKMATE CLARIS DWS, THERE WAS NO SIGNAL TO THE MONITORS AND THEY WERE BLACK. A RED LIGHT STARTED BLINKING ON THE ON/OFF BUTTON. ALL OF THE CABLES AND CONNECTIONS WERE VERIFIED, AND EVERYTHING WAS OKAY. SINCE THE EP RECORDING SYSTEM WAS NOT WORKING, THE PHYSICIAN CANCELED THE 1ST PROCEDURE AND A NON-ABBOTT SYSTEM WAS USED FOR THE 2ND PROCEDURE. ONCE THE ABBOTT SYSTEM WAS OUT OF THE EP ROOM, ALL CABLES WERE UNPLUGGED, THE POWER CORD WAS REPLACED, EVERYTHING WAS PLUGGED IN AGAIN AND THE DWS STARTED WORKING NORMALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15887448 ↗
• MalfunctionOct 11, 2022Failure to Power Up; Unexpected Shutdown; Failure to Power Up; Unexpected Shutdown

  DURING DEVICE PREPARATION WITH THE PATIENT IN THE ROOM, A COMMUNICATION ISSUE OCCURRED AND THE PROCEDURE WAS CANCELLED. THE COMPUTER TURNED OFF UNEXPECTEDLY AND COULD NOT BE TURNED BACK ON. THE SYSTEM WAS ATTEMPTED TO RESTARTED, THE POWER CABLE WAS CHANGED AND THE POWER SOURCE WAS CHANGED WHICH DID NOT RESOLVE THE ISSUE AND THE CASE WAS CANCELLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15581605 ↗
• MalfunctionApr 5, 2022No Display/Image; No Display/Image

  DURING DEVICE PREPARATION FOR THE PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, WHILE THE PATIENT WAS PREPPED, THE WORKMATE CLARIS WAS POWERED ON AND THERE WAS NO DISPLAY WHICH CAUSED A DELAY. THE CONVERSION CABLE BETWEEN THE DISPLAY AND DVI WAS REPLACED, THE DVI CABLE WAS REPLACED, THE CONNECTIONS WERE CHECKED, THE RECEPTION SETTINGS WERE CHECKED, THE DWS WAS RESTARTED AND DISCHARGED, BUT THE ISSUE PERSISTED. THE WORKMATE CLARIS WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14015857 ↗
• MalfunctionDec 9, 2021Failure to Power Up; Failure to Power Up

  DURING THE PROCEDURE, THE SYSTEM WOULD NOT BOOT UP AND THE DISPLAY WOULD NOT APPEAR ON THE MONITORS AND THE PROCEDURE WAS CANCELLED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12967353 ↗
• MalfunctionOct 11, 2021Failure to Power Up; Output Problem; Failure to Power Up; Output Problem

  DURING THE PROCEDURE, THE SYSTEM WOULD NOT POWER UP AND THE CASE WAS CANCELLED. THE CASE STARTED AS USUAL, A FEW MINUTES PASSED AND AN ERROR WAS NOTED ON THE SCREEN STATING: ¿928-FATAL PCIE ERROR.PCIE ERROR DETECTED SURPRISE LINK DOWN ERROR ON SLOT4, GFERRSTS:0X40 XPUNCERRSTS:0X0 UNCERRTS: 0X20. PRESS ENTER TO CONTINUE.¿ WHEN ENTER WAS PRESSED, THE EQUIPMENT TURNED OFF. WHEN THE EQUIPMENT WAS TURNED ON AGAIN, THE FOLLOWING MESSAGE WAS NOTED: ¿WINDOWS ERROR RECOVERY. WINDOWS FAILED TO START. A RECENT HARDWARE OR SOFTWARE CHANGE MIGHT BE CAUSE¿ WITH ONLY TWO OPTIONS TO CHOOSE FROM: 1-LAUNCH STARTUP REPAIR 2-START WINDOWS NORMALLY. THE FIRST OPTION WAS CHOSEN, AND THE FOLLOWING WAS NOTED: ¿ AN INTERNAL ERROR OCCURRED. THE FOLLOWING INFORMATION MIGHT HELP YOU RESOLVE THE ERROR: THE SYSTEM CANNOT FIND THE FILE SPECIFIED.(0X80070002)¿ WHEN SELECTING OK TO CONTINUE, THE FOLLOWING OPTIONS DISPLAYED: 1-STARTUP REPAIR 2-SYSTEM RESTORE 3-SYSTEM IMAGE RECOVERY 4-WINDOWS MEMORY DIAGNOSTIC 5-COMMAND PROMPT. CAPITAL SERVICES STATED TO SELECT STARTUP REPAIR AND IMMEDIATELY AN ERROR RETURNS STATING: ¿POST ERROR¿ AND THE CASE WAS CANCELLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12608964 ↗
• MalfunctionSep 17, 2021Communication or Transmission Problem; Communication or Transmission Problem

  MANUFACTURER REPORT NUMBERS: 2184149-2021-00286, 2184149-2021-00288. DURING THE PROCEDURE, AFTER BOOTING ON THE SYSTEM, PACING WAS PERFORMED AND SUCCESSFUL MEASUREMENT AND PATIENT DIAGNOSIS WAS DONE. AFTER PRESSING THE ABLATION BUTTON, A HARDWARE MALFUNCTION MESSAGE APPEARED ON THE SYSTEM MONITORING SCREEN: "NMI: PARITY CHECK / MEMORY PARITY ERROR. THE SYSTEM HAS HALTED" AND THE SYSTEM COULD NOT OPERATE AS INTENDED. THE DWS AND THE CPU WERE RESTARTED, BUT THE ISSUE PERSISTED. AFTER OVERALL PATIENT CONDITION ASSESSMENT, IT WAS DECIDED TO STOP THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES TO THE PATIENT DUE TO THESE ISSUES. PRODUCT REPLACEMENT IS NOT POSSIBLE FOR THIS CUSTOMER, SO NO EQUIPMENT WILL BE RETURNING FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12490826 ↗
• MalfunctionSep 9, 2021Failure to Analyze Signal; Failure to Analyze Signal

  DURING AN ELECTROPHYSIOLOGICAL PROCEDURE, THE DISPLAY OF LIVE SIGNALS BECAME DELAYED BY APPROXIMATELY 30 SECONDS AND THE PROCEDURE WAS CANCELLED WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12445874 ↗
• MalfunctionAug 20, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  DURING THE PROCEDURE, THERE WAS NO DISPLAY FROM THE TWO MONITORS AND THE CASE WAS CANCELLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12348222 ↗
• MalfunctionMay 20, 2021Failure to Power Up; Application Program Version or Upgrade Problem; Failure to Power Up; Application Program Version or Upgrade Problem

  POST NETWORK CONFIGURATION CLARIS 1.2 WOULD NOT BOOT TO APPLICATION. THE COMPUTER WAS TAKEN OFF THE DOMAIN TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED. THE DEVICE WAS RETAINED THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11855202 ↗
• MalfunctionMay 20, 2021Application Program Version or Upgrade Problem; Communication or Transmission Problem; Application Program Version or Upgrade Problem; Communication or Transmission Problem

  THE CLARIS COLLECT LOGS FUNCTION DOES NOT WORK AFTER THE 1.2 UPGRADE. THERE WAS NO PATIENT INVOLVED. A NEW COMPUTER HAS BEEN INSTALLED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11854606 ↗

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-1855-2021 · May 5, 2021 · Terminated
  WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012
• 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