EnSite™ NavX™ EN0010-100003331Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05414734210003), received between Aug 26, 2019 and Feb 22, 2021 — classified as 1 injury, 1 malfunction.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 22, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  RELATED MANUFACTURER REPORT NUMBERS: 2184149-2021-00032. DURING THE PROCEDURE, AFTER THE PATIENT WAS PREPPED, WHEN THE PATCH WAS VALIDATED, THE SYSTEM SHOWED A LOCATION SHIFT ERROR. THE SYSTEM WAS POWER CYCLED SEVERAL TIMES AND THE AMPLIFIER WAS DISCONNECTED AND RECONNECTED, BUT THE ISSUE PERSISTED. THE PROCEDURE WAS CANCELLED DUE TO THESE ISSUES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11357631 ↗
• InjuryAug 26, 2019Communication or Transmission Problem; Communication or Transmission Problem

  RELATED MANUFACTURING REF: 2184149-2019-00153. DURING A PULMONARY VEIN ISOLATION PROCEDURE, THE TACTISYS WOULD NOT CONNECT AND THE PROCEDURE WAS SIGNIFICANTLY DELAYED. AFTER VALIDATION, THE LIGHT ON THE TACTISYS WAS AMBER COLORED AND THE SYSTEM STATED, "SEARCHING FOR TACTISYS." THE LIGHT WOULD NOT TURN GREEN SO THE TACTISYS WAS RESTARTED AND THE NETWORK CABLES WERE VERIFIED WITH NO RESOLUTION. THE ETHERNET CABLE WAS REPLACED AND ENSITE WAS RESTARTED WITH NO RESOLUTION. THE CASE WAS CLOSED OUT AND RESUME STUDY AND REVALIDATION OF THE PATCHES WAS NOT POSSIBLE. THE ERROR MESSAGE "NAVX VALIDATION FAILED. THE DATA MODULE IS INTENDED FOR SINGLE USE ONLY" DISPLAYED. AFTER 30 MINUTES OF TROUBLESHOOTING, THE PROCEDURE WAS CONTINUED WITH A DIFFERENT CATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT DUE TO THE DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8932316 ↗