WorkMate Claris™ H700169Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 05415067001696), received between Dec 13, 2018 and Feb 27, 2026 — classified as 16 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (27 reports).

3 other recalls cover devices cleared under the same FDA submission (K151911, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionJun 27, 2025Communication or Transmission Problem; Communication or Transmission Problem

  DURING A PFA PVI PROCEDURE, A COMMUNICATION ISSUE OCCURRED AND THE PROCEDURE WAS CANCELLED. THERE WERE NO SIGNALS ON THE WORKMATE CLARIS SYSTEM, AND AN ERROR MESSAGE WAS NOTED STATING: "CHECK CONNECTIONS". THE CONNECTIONS WERE CHECKED AND THE SYSTEM WAS REBOOTED WHICH DID NOT RESOLVE THE ISSUE AND THE PROCEDURE WAS CANCELLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22345394 ↗
• MalfunctionJan 16, 2025Communication or Transmission Problem; Communication or Transmission Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, WHILE THE PATIENT WAS BEING INTUBATED, THERE WAS A COMMUNICATION ISSUE WITH THE WORKMATE AMPLIFIER RESULTING IN CANCELLATION OF THE PROCEDURE. AN ERROR MESSAGE ON THE WORKMATE CLARIS SYSTEM WAS OBSERVED STATING THE WORKSTATION AND AMPLIFIER WERE NOT COMMUNICATING. AFTER 45 MINUTES OF TROUBLE SHOOTING, THE PROCEDURE WAS CANCELED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21169107 ↗
• MalfunctionJul 25, 2024Output Problem; Output Problem

  DURING A LEFT BRANCH STIMULATION PROCEDURE, OUTPUT ISSUES WITH THE AMPLIFIER RESULTED IN THE PROCEDURE BEING CANCELLED. IT WAS NOT POSSIBLE TO LAYOUT AN ECG AND TO LAUNCH THE STIM. A MESSAGE ON THE SCREEN DISPLAYED, "AMPLIFIER ERROR". THE AMPLIFIER WAS RESTARTED BUT THIS DID NOT RESOLVE THE ISSUE. THE PROCEDURE WAS CANCELLED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19828465 ↗
• MalfunctionJun 27, 2024Communication or Transmission Problem; Communication or Transmission Problem

  DURING AN ATRIAL FLUTTER PROCEDURE THERE WERE COMMUNICATION ISSUES WITH THE WORKMATE CLARIS AMPLIFIER, RESULTING IN A DELAY. THE WORKMATE CLARIS SYSTEM WAS POWERED ON AND OFF FOUR TIMES TO RESOLVE THE ISSUE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19630631 ↗
• MalfunctionMay 23, 2024Communication or Transmission Problem; Communication or Transmission Problem

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, COMMUNICATION ISSUES RESULTED IN A PROCEDURAL DELAY. THE WORKMATE CLARIS AMPLIFIER WOULD NOT COMMUNICATE WITH THE DWS. THE FIBER OPTIC CONNECTIONS WERE CHECKED MULTIPLE TIMES. THE AMPLIFIER AND DWS WERE BOTH SHUT DOWN AND RE-STARTED, AND THE FIBER OPTIC CABLE WAS REPLACED, BUT THE ISSUE PERSISTED. THE AMPLIFIER WAS REPLACED WHICH RESOLVED THE ISSUE AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19386718 ↗
• MalfunctionFeb 23, 2024Communication or Transmission Problem; Communication or Transmission Problem

  DURING PREPARATION FOR THE AF/AFL PROCEDURE WITH THE PATIENT ON THE TABLE, THE AMPLIFIER DID NOT CONNECT TO THE DWS AND THE PROCEDURE WAS CANCELLED. THE FIBER OPTIC CABLE CONNECTING THE CLARIS AMPLIFIER TO THE DWS COMPUTER TOWER WAS TESTED AND REPLACED, THE MEDIA CONVERTER AND ETHERNET CABLE FROM THE MEDIA CONVERTER TO THE DATA PORT ON THE CLARIS AMPLIFIER WERE REPLACED. THE SYSTEM WAS REBOOTED WHICH DETERMINED THE ISSUE WAS DUE TO THE AMPLIFIER AND THE PROCEDURE WAS CANCELLED. THE PROCEDURE WILL BE RESCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18768405 ↗
• MalfunctionDec 19, 2023Communication or Transmission Problem; Communication or Transmission Problem

  FOLLOW UP REPORT NEEDED TO INCLUDE PATIENT INFORMATION AND UPDATED EVENT DESCRIPTION. DURING THE PREMATURE VENTRICULAR CONTRACTION PROCEDURE, COMMUNICATION ISSUES WITH THE AMPLIFIER WHICH COULD NOT BE RESOLVED RESULTED IN THE PROCEDURE BEING CANCELLED. THE PATIENT WAS ON THE TABLE BUT PRIOR TO GAINING ACCESS, IT WAS NOTED THERE WERE INTERMITTENT ¿AMPLIFIER IS DISCONNECTED¿ MESSAGES. THERE WERE NO ERROR MESSAGES UNDER COMMUNICATION TEST FIELD. THE FIBER OPTIC AND THE MEDIA CONVERTER WERE REPLACED BUT THE ISSUE WAS NOT RESOLVED AND THE PROCEDURE WAS CANCELLED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE HAS BEEN RESCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18356135 ↗
• MalfunctionSep 26, 2023Signal Artifact/Noise; Signal Artifact/Noise

  DURING A HIS PROCEDURE, IT WAS REPORTED THAT THE ECG AND INTRACARDIAC SIGNALS WERE NOT DISPLAYED, RESULTING IN CANCELLATION OF THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17820856 ↗
• MalfunctionAug 1, 2023Communication or Transmission Problem; Communication or Transmission Problem

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THE AMPLIFIER SPORADICALLY DISCONNECTED FROM THE SYSTEM AND THE PROCEDURE WAS CANCELED. THE SYSTEM WAS POWER CYCLED WHICH DID NOT RESOLVE THE ISSUE AND THE CASE WAS CANCELLED WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17436366 ↗
• MalfunctionJan 18, 2023Communication or Transmission Problem; Communication or Transmission Problem

  DURING PREPARATION FOR THE PROCEDURE, WITH THE PATIENT IN THE ROOM, IT WAS NOT POSSIBLE TO ESTABLISH A CONNECTION WITH THE AMPLIFIER. ALL CONNECTIONS WERE CHECKED WITHOUT SUCCESS AND THE CASE WAS CANCELLED WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16193671 ↗
• MalfunctionDec 12, 2022Output Problem; Output Problem

  DURING DEVICE PREPARATION FOR AN ATRIAL FIBRILLATION PROCEDURE, IT WAS REPORTED THAT AN AMPLIFIER ERROR MESSAGE WAS RECEIVED - RATE DETECTION DISABLED RESULTING IN CANCELLATION OF THE PROCEDURE. THE ERRORS WERE CLEARED BUT THE ISSUE REMAINED. THE PROCEDURE WAS CANCELLED AFTER THE PATIENT WAS AWAKENED FROM GENERAL ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15958816 ↗
• MalfunctionDec 6, 2022Communication or Transmission Problem; Communication or Transmission Problem

  DURING AN ATRIAL FLUTTER PROCEDURE, A COMMUNICATION ISSUE OCCURRED WHICH CAUSED A DELAY. DURING THE PROCEDURE, THE RECORDING SPONTANEOUSLY STOPPED AND AN AMPLIFIER ERROR WAS NOTED ON REAL THE SCREEN (EKG WAS STILL OK). ADDITIONALLY, IT WAS NOT POSSIBLE TO CHANGE THE CHANNEL FOR STIMULATION AND MAKE AN "UPDATE REVIEW" OR BEGIN A RECORDING OF THE PROCEDURE WITH "RECORD." THE NURSE LEFT THE STUDY, SHUT OFF THE AMPLIFIER AND THE COMPUTER WHICH DID NOT RESOLVE THE ISSUE. THE ERROR MESSAGE WAS REMOVED BY CLICKING IN THE MESSAGE AND CLICKING DELETE ERROR. THE AMPLIFIER ERROR MESSAGE DISAPPEARED, BUT IT WAS STILL NOT POSSIBLE TO CHANGE THE CHANNEL FOR STIMULATION AND TO BEGIN RECORDING AND THE CASE WAS CANCELLED WITH NO CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15927117 ↗
• MalfunctionOct 12, 2022Communication or Transmission Problem; Communication or Transmission Problem

  DURING AN ATRIOVENTRICULAR NODAL REENTRANT PROCEDURE, A COMMUNICATION ISSUE OCCURRED WHICH CAUSED A DELAY. AS THE SYSTEM WAS STARTED, ALL THE CONNECTIONS WERE OPERATIONAL. TEN MINUTES INTO THE PROCEDURE, THE AMPLIFIER DISCONNECTED. ALL SYSTEMS WERE REBOOTED WHICH DID NOT RESOLVE THE ISSUE. THE FIBER OPTIC CABLE BETWEEN THE AMPLIFIER AND DWS WAS CHANGED AS WELL AS THE MEDIA CONVERTER, HOWEVER THE ISSUE REMAINED. THE AMPLIFIER CONNECTION WAS CHECKED FOR ERROR MESSAGES, BUT THERE WERE NONE. THE SYSTEM WAS TURNED OFF AND ON AGAIN AND IT STARTED WORKING. AFTER 1 HOUR OF WAITING, THE AMPLIFIER HAD NOT DISCONNECTED AND THE PROCEDURE CONTINUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15586397 ↗
• MalfunctionSep 12, 2022Communication or Transmission Problem; Communication or Transmission Problem

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THERE WAS NO COMMUNICATION BETWEEN THE AMPLIFIER AND THE PC AND THE PROCEDURE WAS CANCELLED. THERE WERE NO CONSEQUENCES TO THE PATIENT AND THE PROCEDURE HAS BEEN RESCHEDULED. A NEW AMPLIFIER WAS OBTAINED WHICH RESOLVED THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15401037 ↗
• MalfunctionJun 10, 2022Communication or Transmission Problem; Communication or Transmission Problem

  DURING THE PROCEDURE, THE SYSTEM DISPLAYED AN ERROR MESSAGE INDICATING THE AMPLIFIER WAS DISCONNECTED AND THE PROCEDURE WAS CANCELLED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14654378 ↗
• MalfunctionNov 12, 2021Communication or Transmission Problem; Communication or Transmission Problem

  DURING THE PROCEDURE, AN ERROR MESSAGE APPEARED ON THE AMPLIFIER STATING "AMPLIFIER PACKET RATE OUT OF BOUNDS CAME OUT: 1795 HZ. CALL TECH SUPPORT". THE ERROR MESSAGE WAS ABLE TO BE CLEARED, BUT THE AMPLIFIER WAS UNABLE TO STIMULATE. THE PROCEDURE WAS ABORTED DUE TO THIS ISSUE AND THE PROCEDURE WILL BE RESCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12805918 ↗
• MalfunctionOct 29, 2021Communication or Transmission Problem; Communication or Transmission Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, SIGNALS COULD NOT BE DISPLAYED. AN ERROR MESSAGE WAS NOTED STATING: CHECK THE AMPLIFIER AND CONNECTIONS TO THE DISPLAY WORKSTATION. TROUBLESHOOTING INVOLVED MULTIPLE RESTART OF ALL DEVICES, CABLES WERE CHECKED, THE CONVERTER WAS CHECKED AND THE FIBER OPTIC CABLE WAS REPLACED WHICH DID NOT RESOLVE THE ISSUE. THE PROCEDURE WAS CANCELLED AND THE PATIENT WAS TAKEN TO ANOTHER ROOM WHERE CARTO WAS PERFORMED WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12719272 ↗
• MalfunctionMay 26, 2021Communication or Transmission Problem; Communication or Transmission Problem

  DURING THE PROCEDURE WITH THE PATIENT ON THE TABLE, THE AMPLIFIER DID NOT COMMUNICATE WITH THE PC AND THE PROCEDURE WAS CANCELLED. WHEN POWERED ON, ONLY ONE BEEP WAS HEARD INSTEAD OF THREE. TROUBLESHOOTING DID NOT RESOLVE THE ISSUE AND THE CASE WAS CANCELLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11884865 ↗
• InjuryJan 25, 2021Communication or Transmission Problem; Communication or Transmission Problem

  PRIOR TO THE PROCEDURE WITH THE PATIENT IN THE ROOM, THE AMPLIFIER WOULD NOT CONNECT WITH THE CLARIS PC AND THE PROCEDURE WAS CANCELLED. THE FIBER OPTIC AND MEDIA CONVERTER WERE REPLACED WITH NO RESOLUTION AND THE PROCEDURE WAS RESCHEDULED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT DUE TO THE CANCELLATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11222749 ↗
• InjuryDec 10, 2020Communication or Transmission Problem; Communication or Transmission Problem

  DURING SUPRAVENTRICULAR TACHYCARDIA ABLATION PROCEDURE, THE AMPLIFIER DISPLAYED A COMMUNICATION ERROR, THE SIGNALS WERE LOST, AND THE PROCEDURE WAS CANCELLED. PRIOR TO THE REPORTED ISSUE, THE NON-ABBOTT SYSTEM AND WORKMATE CLARIS DISPLAYED ALL SIGNALS. THE MEDIA CONVERTER WAS CHECKED AND THE LIGHT APPEARED GREEN AS EXPECTED. MOREOVER, THE AMPLIFIER PORT ON THE WORKMATE CLARIS ALSO SHOWED GREEN LIGHTS AS EXPECTED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10984193 ↗
• InjuryDec 10, 2020Output Problem; Output Problem

  RELATED MANUFACTURER REF: 2184149-2020-00222. DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, THERE WAS AN AMPLIFIER ERROR THAT STATED "PACKET RATE OUT OF BOUNDS" AND THE PROCEDURE WAS CANCELLED. THE ERROR WAS CLEARED AND THE RATE DETECTION ALGORITHM WAS TURNED OFF, BUT THE ISSUE REMAINED. THE AMPLIFIER WAS EXCHANGED, BUT THE SAME ISSUE HAPPENED WITH THE SECOND AMPLIFIER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10983145 ↗
• InjuryDec 10, 2020Output Problem; Output Problem

  RELATED MANUFACTURER REF: 2184149-2020-00221. DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, THERE WAS AN AMPLIFIER ERROR THAT STATED "PACKET RATE OUT OF BOUNDS" AND THE PROCEDURE WAS CANCELLED. THE ERROR WAS CLEARED AND THE RATE DETECTION ALGORITHM WAS TURNED OFF, BUT THE ISSUE REMAINED. THE AMPLIFIER WAS EXCHANGED, BUT THE SAME ISSUE HAPPENED WITH THE SECOND AMPLIFIER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10983131 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K151911, 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