EnSite™ ENSITE-SW-2.0.1Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05415067046703), received between Nov 23, 2025 and Feb 4, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2026Display or Visual Feedback Problem

  DURING A TYPICAL ATRIAL FLUTTER PROCEDURE, THERE WAS A DELAY DUE TO A DISPLAY ISSUE. USING THE ENSITE X V2.0.1 IN VOXEL MODE, THE ADVISOR HD GRID CATHETER WAS INSERTED IN THE RIGHT ATRIUM. THE CATHETER HAD APPEARED INSIDE THE SHEATH IN THE 3D SYSTEM BUT APPEARED OUTSIDE THE SHEATH ON THE DSA IMAGES. TROUBLESHOOTING INCLUDED REINSERTING THE TAIL WIRE, RESTARTING THE ENSITE X DWS, AND REPLACING THE CATHETER, BUT THE ISSUE PERSISTED. THE ISSUE WAS LATER RESOLVED BY SWITCHING THE VOXEL MODE TO NAVX MODE. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24257454 ↗
• MalfunctionNov 23, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THERE WAS A SHEATH FILTER AND COMMUNICATION ISSUES WITH THE ENSITE X SOFTWARE, AMPLIFIER, AND DISPLAY WORKSTATION RESULTING IN A DELAY. THE ENSITE X AMPLIFIER WAS FLASHING RED AND THE CATHETER WAS UNABLE TO BE CONNECTED. IT ALSO KEPT SHOWING THAT THE CATHETER WAS IN THE SHEATH AND NO CATHETER DATA COULD BE DISPLAYED. ADDITIONALLY, DURING THE PROCEDURE THERE WAS A CONTACT FORCE ERROR WITH LOSS OF THE PRESSURE VALUE. DURING THIS THE MAGNETIC POINT WOULD DISCONNECT. AFTER REPLACING THE ENSITE X DISPLAY WORKSTATION THE CONTACT FORCE ISSUE RESOLVED. TROUBLESHOOTING ALSO INCLUDED REPLACING THE CATHETER AND RESTARTING THE ENSITE X DISPLAY WORKSTATION AT LEAST 3 TIMES, BUT THE SHEATH FILTER ISSUE PERSISTED. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23627065 ↗