EnSite™ ENSITE-SW-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05415067053435), received between Mar 12, 2026 and Mar 12, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (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

Recent adverse event reports

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

• MalfunctionMar 12, 2026Application Program Freezes or Fails to Launch

  DURING THE SUPRAVENTRICULAR TACHYCARDIA AND PULSED FIELD ABLATION PULMONARY VEIN ISOLATION PROCEDURE, THERE WAS A DELAY DUE TO ENSITE X FREEZE ISSUES. THE ENSITE X FROZE WHEN ATTEMPTING TO SAVE AND MAKE ICE CONTOUR WITH THE ENSITE ECHO MODULE. WHILE AUTOMAPPING WITH THE ADVISOR HD GRID X CATHETER IN VOXEL MODE, THE ENSITE FROZE. THE COMPUTER WAS RESTARTED AND THE CASE WAS RELOADED, BUT THE ENSITE FROZE AGAIN ONCE LOADED. THE COMPUTER WAS RESTARTED AGAIN AND A NEW CASE WAS STARTED FOR THE EXISTING PATIENT, WHICH LOADED A FREEZE AGAIN. EVERYTHING WAS DISCONNECTED, THE DWS, ENSITE AMPLIFIER, AND CURRENT GENERATOR WERE RESTARTED IN THAT ORDER, AND A BRAND NEW CASE WAS ABLE TO BE STARTED. THE PROCEDURE WAS COMPLETED WITHOUT ENSITE ECHO. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24586655 ↗