EnSite™ ENSITE-R-DWS-1.1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05415067037756), received between Apr 8, 2026 and Apr 8, 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 18, 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.

• MalfunctionApr 8, 2026Application Program Freezes or Fails to Launch

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THERE WAS A PROCEDURAL DELAY. IN VOXEL MODE, ON ENSITE X 3.1.1 SOFTWARE, IT WAS NOTED THAT THE SYSTEM SUDDENLY BECAME CHOPPY AND ABNORMAL WHEN THE STUDY WAS ENTERED AND ANY OPERATION WAS ATTEMPTED TO BE PERFORMED. THE SURFACE AND INTRACARDIAC ELECTROGRAMS DISPLAYED AS A MAGENTA-COLORED BASELINE, AND THE SYSTEM FROZE. THE CONNECTIONS WERE CHECKED AND CONFIRMED TO BE CORRECT. A FORCED LOGOUT OF THE SYSTEM WAS PERFORMED USING CTRL + ALT + DELETE AND THE SYSTEM WAS REBOOTED, BUT THE ISSUE PERSISTED EVEN AFTER FIVE TO TEN REBOOTS. WHEN SHUTTING DOWN THE SYSTEM, AN ERROR STATING "HARDWARE ERROR" DISPLAYED JUST BEFORE THE SYSTEM POWERED OFF. THE ISSUE INTERFERED WITH LOADING PRESETS, ADDING CATHETERS, AND PERFORMING SET METAL AND INITIATING MAPPING. WHEN THE ADVISOR HD GRID X AND TACTIFLEX CATHETERS WERE AUTOMATICALLY RECOGNIZED, THE SYSTEM WAS ABLE TO MAINTAIN STABLE PERFORMANCE, AND MINIMAL NAVIGATION WAS POSSIBLE IN NAVX MODE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY PERFORMING ONLY PVI IN NAVX MODE UNDER FLUOROSCOPIC AND ICE GUIDANCE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24817227 ↗