WorkMate Claris™ H700131Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05415067001313), received between Nov 1, 2024 and Nov 1, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Signal Artifact/Noise” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 1, 2024Signal Artifact/Noise; Signal Artifact/Noise

  DURING AN AV NODE ABLATION PROCEDURE, THERE WAS NOISE ON SURFACE ECGS AND ABLATION CATHETER WHILE USING THE ENSITE PRECISION MAPPING SYSTEM RESULTING IN CANCELLATION OF THE PROCEDURE. THE RECORDCONNECT WAS BYPASSED, BUT THE ISSUE DID NOT RESOLVE. THE RIGHT LEG PATCH, ECG LEADS, CATHETER, AND CONNECTING CABLE WERE REPLACED, BUT THE ISSUE DID NOT RESOLVE. THE CABLE MANAGEMENT AND NOTCH FILTER WERE CHECKED, AND THE SYSTEM WAS REBOOTED, BUT THE ISSUE DID NOT RESOLVE. THE PROCEDURE WAS CANCELLED DUE TO THIS ISSUE. LATER THE ECG CABLE SET WAS REPLACED AND THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20589395 ↗

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-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
• 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