WorkMate™ H700088Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05415067000880), received between May 21, 2020 and Jan 11, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Communication or Transmission Problem” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 11, 2024Communication or Transmission Problem; Communication or Transmission Problem

  RELATED MANUFACTURING REF: 2184149-2024-00009. DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THERE WAS A COMMUNICATION ISSUE WITH THE AMPERE RF GENERATOR AND THE WORKMATE CATHETER INTERFACE MODULE RESULTING IN CANCELLATION OF THE PROCEDURE. WHEN THE ABLATION CABLE WAS CONNECTED TO THE AMPERE RF GENERATOR, THE ABLATION EGM WAS SHOWING BUT OTHER EGM LIKE THE CS, HIS, AND RV SHOWED AS FLAT BLUE LINES. THE WORKMATE CATHETER INTERFACE MODULE WAS EXCHANGED WITH A SECONDARY ONE, NEW ABLATION CABLES, AND A NEW CATHETER WERE ATTEMPTED, BUT THE ISSUE REMAINED. THE PROCEDURE WAS THEN CANCELLED. REPLACING THE AMPERE RF GENERATOR ALONG WITH THE WORKMATE CATHETER INTERFACE MODULE RESOLVED THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18498464 ↗
• InjuryOct 18, 2020Communication or Transmission Problem; Communication or Transmission Problem

  DURING A HIS ABLATION PROCEDURE, IT WAS NOTED THERE WERE NO ABLATION SIGNALS ON THE RECORDING SYSTEM RESULTING IN A DELAY TO THE PROCEDURE. TROUBLESHOOTING INCLUDED RESTARTING THE RECORDING SYSTEM, REOPENING THE STUDY, RESTARTING THE AMPLIFIER, AND CHANGING THE CATHETER INTERFACE MODULE, THE EGM CABLE, THE CATHETER AND THE GENERATOR. NONE OF THE TROUBLESHOOTING RESOLVED THE ISSUE. THE PATIENT WAS MOVED TO A DIFFERENT ROOM AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10695092 ↗
• InjuryMay 21, 2020Environmental Compatibility Problem; Environmental Compatibility Problem

  RELATED MANUFACTURER REFERENCE: 2184149-2020-00055, 2184149-2020-00056. DURING A PROCEDURE, A SALINE BAG RUPTURED CAUSING WATER DAMAGE TO DEVICES. THE PROCEDURE WAS CANCELLED. THE CLARIS EP4 STIMULATOR HAD EVIDENCE OF SALINE FLUID DAMAGE AND HAD FLUID INSIDE THE UNIT. THE SIGNALS WERE INTERMITTENT AND COULD NOT BE REPAIRED. THE DB9 SERIAL TO FIBER MEDIA CONVERTER AND THE CATHETER INPUT MODULE 1 ¿ CM1 PIN BOX BOTH HAD WATER DAMAGE. THERE WAS NO HARM TO THE PATIENT OR THE STAFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10080873 ↗

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