NA DAC-NTRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05415067028884), received between Apr 16, 2024 and Jun 29, 2026 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (6 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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 29, 2026Communication or Transmission Problem

  IT WAS REPORTED DURING AN ABLATION PROCEDURE, THE ELECTRODES WERE CONNECTED BUT WERE NOT SHOWING UP ON THE SCREEN. THE PROCEDURE WAS ABANDONED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25652910 ↗
• MalfunctionJun 29, 2026Communication or Transmission Problem

  IT WAS REPORTED DURING AN ABLATION PROCEDURE, THE ELECTRODES WERE CONNECTED BUT WERE NOT SHOWING UP ON THE SCREEN. THE PROCEDURE WAS ABANDONED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25652907 ↗
• MalfunctionJun 29, 2026Communication or Transmission Problem

  IT WAS REPORTED DURING AN ABLATION PROCEDURE, THE ELECTRODES WERE CONNECTED BUT WERE NOT SHOWING UP ON THE SCREEN. THE PROCEDURE WAS ABANDONED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25652681 ↗
• InjuryFeb 4, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT THE PATIENT'S PROCEDURE WAS ABANDONED DUE TO NON-FUNCTIONAL ADAPTERS. NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24263933 ↗
• InjuryFeb 4, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT THE PATIENT'S PROCEDURE WAS ABANDONED DUE TO NON-FUNCTIONAL ADAPTERS. NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24263878 ↗
• InjuryFeb 4, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT THE PATIENT'S PROCEDURE WAS ABANDONED DUE TO NON-FUNCTIONAL ADAPTERS. NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24263869 ↗
• InjuryApr 16, 2024Connection Problem; Connection Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 3005334138-2024-00142 IT WAS REPORTED THAT DURING A PROCEDURE A MESSAGE WAS RECEIVED STATING THE ELECTRODE HAS BEEN CHANGED. AS SUCH, THE TREATMENT WAS STOPPED, AND THE PATIENT WAS CHANGED TO MEDICATION TREATMENT. REPORTEDLY, THERE WERE NO ADVERSE CONSEQUENCE TO THE PATIENT. A REPLACEMENT ADAPTER AND SAME NEEDLE WERE USED BUT THE ISSUE PERSISTED. HOWEVER, WHEN TROUBLESHOOTING WITH A REPRESENTATIVE¿S ADAPTER CABLE, THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19121554 ↗
• InjuryApr 16, 2024Connection Problem; Connection Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2182269-2024-00009. IT WAS REPORTED THAT DURING A PROCEDURE A MESSAGE WAS RECEIVED STATING THE ELECTRODE HAS BEEN CHANGED. AS SUCH, THE TREATMENT WAS STOPPED, AND THE PATIENT WAS CHANGED TO MEDICATION TREATMENT. REPORTEDLY, THERE WERE NO ADVERSE CONSEQUENCE TO THE PATIENT. A REPLACEMENT ADAPTER AND SAME NEEDLE WERE USED BUT THE ISSUE PERSISTED. HOWEVER, WHEN TROUBLESHOOTING WITH A REPRESENTATIVE¿S ADAPTER CABLE, THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19121544 ↗