NeuroTherm™ DACUK-NTRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05415067021335), received between Jun 15, 2018 and Apr 3, 2019 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (2 reports).

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 18, 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.

• InjuryApr 3, 2019Low impedance; Low impedance

  DURING A BIPOLAR PALISADE ABLATION PROCEDURE, THE IMPEDANCE WAS LOW AND THE GENERATOR EMITTED A BURNING SMELL SO THE PROCEDURE WAS CANCELLED. FOLLOWING THE CANCELLATION, FURTHER TROUBLESHOOTING DETERMINED THE ISSUE WAS DUE TO THE ADAPTER CABLE. A NEW CABLE WAS USED IN ALL PORTS AND THE IMPEDANCE DISPLAYED AS INTENDED AND NO BURNING SMELL WAS NOTED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT DUE TO THE CANCELLATION AND THE PROCEDURE WAS RESCHEDULED FOR A LATER DATE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8477692 ↗
• MalfunctionJun 15, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  RELATED MANUFACTURER REFERENCE NUMBER: (B)(4). DURING A PROCEDURE PORT 1 ON THE GENERATOR DISPLAYED AN UNSAFE PROBE ERROR MESSAGE WHEN GOING INTO LESION MODE. THE PROCEDURE WAS CANCELLED AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER TROUBLESHOOTING DETERMINED THE ISSUE WAS DUE TO TWO GENERATOR ADAPTER CABLES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7604827 ↗
• MalfunctionJun 15, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  RELATED MANUFACTURER REFERENCE NUMBER: 3002953813-2018-00036. DURING A PROCEDURE PORT 1 ON THE GENERATOR DISPLAYED AN UNSAFE PROBE ERROR MESSAGE WHEN GOING INTO LESION MODE. THE PROCEDURE WAS CANCELLED AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER TROUBLESHOOTING DETERMINED THE ISSUE WAS DUE TO TWO GENERATOR ADAPTER CABLES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7604823 ↗