EnSite™ ENSITE-SW-3.1.1Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05415067053121), received between Sep 17, 2025 and Feb 3, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Application Program 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2026Application Program Problem

  DURING A PULSED FIELD ABLATION PROCEDURE, THERE WAS A DELAY DUE TO A GRAPHICAL USER INTERFACE ISSUE. WHEN USING THE ENSITE X SYSTEM (V3.1.1) IN VOXEL MODE, THE VOXEL POINT ACQUISITION AND GEOMETRY ACQUISITION WERE POSSIBLE. DESPITE ACQUIRING MULTIPLE VOXEL POINTS, THE CATHETER ELECTRODE NAVIGATION DISPLAY REMAINED GRAYED - PREVENTING MAP ACQUISITION. WHEN THE MODE WAS SWITCHED FROM VOXEL TO NAVX, THE CATHETER NAVIGATION DISPLAY APPEARED TO HAVE COLLAPSED AND COULD NOT BE DISPLAYED PROPERLY. ADDITIONAL TROUBLESHOOTING INCLUDED REPLACING THE CONNECTION CABLE AND CATHETERS, RESTARTING THE SYSTEM, AND PERFORMING REVALIDATION, BUT THE ISSUE PERSISTED. THE ISSUE WAS RESOLVED BY REPLACING THE ENSITE X SYSTEM WITH A NON-ABBOTT 3D SYSTEM. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24254984 ↗
• MalfunctionJan 8, 2026Erratic or Intermittent Display

  DURING TYPICAL ATRIAL FLUTTER PROCEDURE USING ADVISOR HD GRID IN VOXEL MODE, THE CATHETERS BEGAN TO INTERMITTENTLY DISAPPEAR FROM THE SCREEN UNTIL THEY NO LONGER APPEARED AT ALL RESULTING IN A DELAY. THE EXTENSIONS WERE CHANGED, THE AMPLIFIER WAS RESTARTED, AND THE CATHETERS WERE SWITCHED TO DIFFERENT CHANNELS, BUT THEY STILL DID NOT APPEAR. THE MODE WAS SWITCHED TO NAVX, BUT THE CATHETERS CONTINUED TO BE ABSENT FROM THE SCREEN. THE CASE WAS RESTARTED; HOWEVER, WHEN ATTEMPTING TO RESUME IT, THE SYSTEM DID NOT ALLOW IT BECAUSE A MESSAGE APPEARED ON THE SCREEN STATING THAT THE PATCHES HAD ALREADY EXCEEDED THE TIME LIMIT TO RESUME THE PROCEDURE, EVEN THOUGH THE PATCH VALIDATION HAD BEEN PERFORMED LESS THAN TWO HOURS EARLIER. IT WAS ATTEMPTED TO RESUME UNDER A NEW CASE, BUT IT WAS NOT POSSIBLE BECAUSE THE SAME MESSAGE APPEARED ON THE SCREEN. THE PATCHES WERE REPLACED, AND SINCE PATCHES HAD ALREADY BEEN VALIDATED WITH THE HD GRID MAPPING CATHETER AND THE TACTIFLEX ABLATION CATHETER, BOTH CATHETERS HAD TO BE REPLACED BECAUSE THE SYSTEM DID NOT ALLOW A NEW VALIDATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24012154 ↗
• MalfunctionSep 17, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  DURING A PREMATURE VENTRICULAR CONTRACTION PROCEDURE, THERE WAS A MAPPING SHIFT RESULTING IN A CLINICALLY SIGNIFICANT DELAY. AN RV MODEL AND MAP WAS CREATED THE MAPPING CATHETER. WHEN THE MAPPING CATHETER WAS EXCHANGED WITH AN ABLATION CATHETER TO BEGIN ABLATION, IT WAS NOTED THAT ALL OF THE PRS-P SENSORS TURNED RED. IT APPEARED AS THOUGH THEY WERE STILL IN THE SAME INITIAL LOCATION, HOWEVER, THEY WERE ALL RED. TROUBLESHOOTING INCLUDED ATTEMPTING TO MANUALLY ADJUST THE PRS-PS TO TURN GREEN, BUT THE ISSUE PERSISTED. IN ORDER TO CONTINUE THE PROCEDURE, A NEW MODEL WAS CREATED, FOLLOWED BY RESETTING THE METAL BASELINE, AND CONTINUING TO MAP AND ABLATE. AFTER THE ABLATION WAS COMPLETED, THE PHYSICIAN WAITED TWENTY MINUTES TO MAKE SURE THAT THE PVC¿S WERE GONE. AFTER THE WAITING PERIOD WAS COMPLETED, THE SHEATHS WERE PULLED AND PLANNED TO GET THE PATIENT OFF THE TABLE. AT THIS POINT, THE PVC¿S RETURNED, SO THE PHYSICIAN DECIDED TO GET ACCESS AND PUT THE CATHETERS BACK IN TO ABLATE MORE. HOWEVER, WHEN THE CATHETERS WERE PLACED BACK INTO THE PATIENT, IT WAS CLEAR THAT THE MODEL HAS SHIFTED. THERE WAS NO ERROR MESSAGES DISPLAYED AND NO INDICATORS THAT WOULD SUGGEST THAT THERE WAS ANYTHING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23077886 ↗