WorkMate Claris™ H700123Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 05415067001238), received between Aug 10, 2018 and Feb 21, 2023 — classified as 7 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Application Program Version or Upgrade Problem” (3 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 21, 2023Signal Artifact/Noise; Signal Artifact/Noise

  DURING AN ATRIAL FIBRILLATION PROCEDURE THERE WERE ERROR AND NOISE ISSUES WHICH CAUSED THE PROCEDURE TO BE CANCELLED. WHILE USING CLARIS AND NON-ABBOTT (CARTO) SYSTEMS, THERE WAS A "COMMAND PACKET CONTAINED INCORRECT PARAMETER" ERROR MESSAGE. THE ERROR WAS CLEARED, BUT THE SURFACE ECG SIGNALS WERE BLUE. RIGHT LEG PATCH WAS ON THE PATIENT AND WAS REPLACED BUT THE ISSUE DID NOT RESOLVE. ECG CABLES WERE REPLACED AND THE RECORDCONNECT WAS REPLACED. THE ECG CABLE WAS CONNECTED DIRECTLY TO CLARIS AMPLIFIER AND THE NOTCH FILTER WAS SET TO 60HZ. ATTEMPTED TO RESET THE MP BUT THE ISSUE DID NOT RESOLVE. THE CASE WAS ABANDONED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16409930 ↗
• MalfunctionJan 24, 2022Failure to Power Up; Failure to Power Up

  DURING THE PROCEDURE, THE AMPLIFIER WAS UNABLE TO TURN AND THE CASE WAS CANCELLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13338780 ↗
• MalfunctionJun 3, 2021Display or Visual Feedback Problem; Application Program Version or Upgrade Problem; Display or Visual Feedback Problem; Application Program Version or Upgrade Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, WHEN ABLATING, THE LIVE AND REVIEW SCREENS WENT BLACK. THE ISSUE WAS RESOLVED WITH TECHNICAL ASSISTANCE, AND REBOOTING THE SYSTEM. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11930341 ↗
• MalfunctionMay 20, 2021Loss of Threshold; Application Program Version or Upgrade Problem; Loss of Threshold; Application Program Version or Upgrade Problem

  DURING THE PROCEDURE, THERE WAS INTERMITTENT PACING AND CAPTURE. AT THE START OF THE CASE, ALL 4 PACING CHANNELS WERE SELECTED AND ASSIGNED TO SPECIFIC POLES. CHANNEL 2 WAS SELECTED FIRST. PACING BEHAVED AS EXPECTED. CHANNEL 1 WAS SELECTED NEXT AND PACING APPEARED TO BE OCCURRING, BUT THERE WERE ONLY PACING SPIKES, NO CAPTURE. CHANNEL 1 WAS THEN UNASSIGNED AND REASSIGNED BACK TO THE SAME PACING SITE AS THE ORIGINAL CHANNEL 1 SITE. PACING BEGAN AGAIN AND THE ISSUE WAS RESOLVED. THERE WAS NO CHANGE IN OUTPUT OR CATHETER LOCATION. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE CAUSE WAS ATTRIBUTED TO A RECENT UPGRADE TO WINDOWS 10 OPERATING SOFTWARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11855277 ↗
• MalfunctionMay 19, 2021Display or Visual Feedback Problem; Application Program Version or Upgrade Problem; Display or Visual Feedback Problem; Application Program Version or Upgrade Problem

  FOLLOWING A SOFTWARE UPGRADE TO V1.2, WHEN USING INTERVAL CALIPERS, THERE WERE 2 SETS OF CALIPERS OPENED. WHEN THE RIGHT LEG WAS LOCKED DOWN, THE SECOND SET OF CALIPERS DISAPPEARED. THERE IS NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11851805 ↗
• InjuryJan 8, 2021Failure to Power Up; Communication or Transmission Problem; Failure to Power Up; Communication or Transmission Problem

  DURING THE PROCEDURE, THE SYSTEM HAD DID NOT START. THE AMPLIFIER AND CONNECTIONS WERE CHECKED, BUT THE ISSUE REMAINED. THE PROCEDURE WAS CANCELLED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

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

  MAUDE report 11143175 ↗
• InjuryNov 13, 2020Signal Artifact/Noise; Signal Artifact/Noise

  PRIOR AND DURING THE PROCEDURE, INTERFERENCE WAS NOTED AND THE CASE WAS CANCELLED. DURING THE PROCEDURE, NOISE WAS NOTED. THE CABLES AND ELECTRODES WERE CHANGED WHICH DID NOT RESOLVE THE ISSUE. THE PROCEDURE WAS TERMINATED WITH THE PRESENCE OF PARASITES. THERE WAS NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10839951 ↗
• InjuryOct 10, 2019Failure to Analyze Signal; Failure to Analyze Signal

  DURING THE PROCEDURE, THERE WERE NO EGM OR ECG SIGNALS DISPLAYED ON THE SYSTEM AND THE ERROR MESSAGE "DISCONNECT AMP, 0 DATA PACKET" WAS DISPLAYED. THE PROCEDURE ENDED UP BEING CANCELLED AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9177015 ↗
• InjurySep 10, 2019Failure to Analyze Signal; Failure to Analyze Signal

  DURING A DIAGNOSTIC EXPLORATION PROCEDURE, THE SIGNAL LEADS WOULD NOT DISPLAY ON THE RECORDING SYSTEM AND THE PROCEDURE WAS CANCELLED. THE PROCEDURE WAS COMPLETED AT A DIFFERENT FACILITY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT DUE TO THE CANCELLATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8980860 ↗
• InjuryApr 11, 2019Communication or Transmission Problem; Communication or Transmission Problem

  DURING AN ELECTROPHYSIOLOGY PROCEDURE A CANCELLATION OCCURRED DUE TO SIGNAL LOSS. DURING THE PROCEDURE, WHILE PACING WAS APPLIED, THE CORONARY SINUS CATHETER SIGNAL WAS LOST. WHEN PACING WAS STOPPED TO TROUBLESHOOT, THE SIGNAL FROM THE HIS CATHETER DISAPPEARED ALONG WITH THE INTRACARDIAC SIGNAL. ALL CONNECTIONS WERE CHECKED, CONNECTION CABLES WERE EXCHANGED, A NEW CATHMAP WAS STARTED, THE CATHETERS WERE EXCHANGED, THE SYSTEM WAS RESTARTED, AND A NEW POWER SOURCE WAS USED BUT THE SIGNAL ISSUE COULD NOT BE RESOLVED. AFTER APPROXIMATELY AN HOUR DELAY, IT WAS DECIDED TO CANCEL THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8506096 ↗
• InjuryAug 27, 2018No Display/Image; No Display/Image

  RELATED MANUFACTURING REF: 2030404-2018-00064. DURING AN ATRIAL VENTRICULAR NODE ABLATION, THE ABLATION SIGNALS AND RADIOFREQUENCY DATA WERE UNABLE TO BE SEEN FROM THE AMPERE GENERATOR AND THE PROCEDURE WAS CANCELLED. THE CABLES WERE RECONNECTED, THE GENERATOR SELECTION WAS VERIFIED, AND THE PATCHES WERE CONFIRMED TO BE CONNECTED TO THE PATIENT WITH NO RESOLUTION. THE PROCEDURE WAS CANCELLED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7817914 ↗
• InjuryAug 10, 2018Failure to Power Up; Failure to Power Up

  DURING THE PROCEDURE WITH THE PATIENT ON THE TABLE, THE SYSTEM WAS TURNED ON WITHOUT SUCCESS. THE SYSTEM WAS REBOOTED WHICH DID NOT RESOLVE THE ISSUE. THE PROCEDURE WAS CANCELLED AND WILL BE RESCHEDULED. THERE WERE NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7771613 ↗

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