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EP-WorkMate™ WM-01-1203Recalls & reported problems

St. Jude Medical, Inc. · Recording System · Class 2

All models of EP-WorkMate (4)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734207546), received between Nov 2, 2018 and Nov 2, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Communication or Transmission Problem” (1 report).

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

Device problems

  • Communication or Transmission Problem1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • InjuryNov 2, 2018Communication or Transmission Problem; Communication or Transmission Problem

    AT THE START OF A PROCEDURE, THE ERROR MESSAGE "CHECK ALL CONNECTIONS" WAS DISPLAYED. THE SYSTEM WAS POWER CYCLED BUT THE AMPLIFIER WOULD NOT CONNECT AND THE ISSUE COULD NOT BE RESOLVED. THE PATIENT WAS ON THE PROCEDURE TABLE WHEN THE CASE WAS CANCELLED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8032708 ↗

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Sources and updates

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