EnSite™ ENSITE-SW-3.1Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05415067049704), received between Nov 26, 2024 and Sep 9, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Application Program Problem” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2025Display or Visual Feedback Problem; Application Program Problem; Display or Visual Feedback Problem; Application Program Problem

  DURING A VENTRICULAR TACHYCARDIA PROCEDURE, DISPLAY ISSUES WITH THE ENSITE X SOFTWARE RESULTED IN CANCELLATION OF THE PROCEDURE. WHEN USING THE ENSITE X SYSTEM IN VOXEL MODE AND MAPPING WAS DONE USING THE ADVISOR HD GRID CATHETER, EVERYTHING WAS NORMAL. HOWEVER, WHEN ARRIVING AT THE ANTERIOR APICAL PART OF THE LEFT VENTRICLE, THE CATHETER HAD DISAPPEARED. EVERYTHING ELSE REMAINED THE SAME AND THE GREEN LIGHT WAS ON BUT, ONLY IN THAT PARTICULAR SPOT DID THE CATHETER DISAPPEAR. SWITCHING TO NAVX MODE CAUSED THE CATHETER TO REAPPEAR BUT, AFTER CARDIOVERSION, WHEN THE MODE WAS SWITCHED BACK TO VOXEL, THE DISTORTION METER WAS FROZEN IN RED. THE MODE WAS SWITCHED OFF VOXEL AND THE CATHETER WAS REINSERTED INTO THE PATIENT WHICH RESOLVED THE DISTORTION METER ISSUE, BUT THE CATHETER DISAPPEARED. CHANGING THE CATHETER DID NOT RESOLVE THE ISSUE. AFTER TRYING TO MAP FOR A WHILE LONGER, THE DECISION TO END THE PROCEDURE WAS MADE DUE TO THE ISSUE PERSISTING. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23012347 ↗
• MalfunctionJun 16, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  DURING A SUPRAVENTRICULAR TACHYCARDIA VOXEL PROCEDURE, DISPLAY ISSUES RESULTED IN A PROCEDURAL DELAY. THE MAP SHIFTED NOTICEABLY WITHOUT PATIENT MOVEMENT. THE CASE WAS RESTARTED TWICE AND REMAPPED, AND THE METAL BASELINE WAS RESET. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22211849 ↗
• MalfunctionMay 5, 2025Application Program Problem; Application Program Problem

  DURING AN ATRIAL TACHYCARDIA PROCEDURE, ISSUES WITH THE SOFTWARE RESULTED IN A PROCEDURAL DELAY. WHEN USING THE ENSITE X V3.1.1 IN VOXEL MODE, MAPPING WAS PERFORMED WITHOUT ANY ISSUES WHEN USING THE ADVISOR HD GRID CATHETER. ONCE THE ADVISOR VL CATHETER WAS CONNECTED TO CONTINUE MAPPING, THE STUDY CRASHED WITH THE ERROR MESSAGE: "UNEXPECTED ERROR OCCURRED. APPLICATION EXITED". TROUBLESHOOTING INCLUDED REPLACING THE DIRECT CABLE, REPLACING THE CATHETER, USING A DIFFERENT PORT, TRYING "RESUME STUDY", AND RESTARTING THE DWS AND THE AMPLIFIER BUT ISSUE PERSISTED. THE ISSUE WAS RESOLVED AFTER SWITCHING FROM VOXEL MODE TO NAVX MODE AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21960518 ↗
• MalfunctionJan 17, 2025Electromagnetic Interference; Application Program Problem; Electromagnetic Interference; Application Program Problem

  DURING THE PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, ISSUES WITH THE SOFTWARE RESULTED IN A PROCEDURAL DELAY. THE ELECTRODE KIT WAS APPLIED TO THE PATIENT, THE ABLATION CATHETER AND THE MAPPING CATHETER WERE INSERTED INTO THE CARDIAC CAVITY AND CONNECTED TO ENSITE. IT WAS NOTED THAT DISTORTION METER ON THE DWS EXCEEDED THE LIMIT (II), TURNED RED, AND FROZE. THE NAVIGATION DISPLAYS OF THE CATHETERS ALSO FROZE. NO ERROR MESSAGE WAS DISPLAYED. THE SHEATH WAS MOVED, THE FIELD FRAME WAS ADJUSTED, THE LOCATION OF THE PRS-A WAS CHECKED WITH A TOUCH, EACH PRS CABLE WAS RECONNECTED, THE CABLES OF BOTH CATHETERS WERE RECONNECTED, THE ENSITE WAS RESTARTED, AND THE ABLATION CATHETER WAS REPLACED. THE ENSITE WAS RESTARTED AGAIN AND THE DISTORTION METER AND NAVIGATION DISPLAY FREEZE WERE RESOLVED. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21179889 ↗
• MalfunctionNov 26, 2024Application Program Problem; Application Program Problem

  DURING A PREMATURE VENTRICULAR CONTRACTION PROCEDURE, THERE WAS A CRASH ON THE DISPLAY WORKSTATION RESULTING IN A 20 MINUTE DELAY. WHEN CONNECTING A NEW TACTIFLEX CATHETER TO THE AMPLIFIER. THE DISPLAY WORKSTATION SHOWED AN UNEXPECTED ERROR, AND THE STUDY CLOSED ITSELF. THE STUDY COULD NOT BE RESTARTED UNTIL THE TACTIFLEX SE WAS DISCONNECTED. THIS WAS THE FIRST TIME USING THE DISPLAY WORKSTATION AFTER PERFORMING THE UPDATE TO V3.1. THE PROCEDURE WAS COMPLETED IN NAVX MODE WITH A NON-SE CATHETER WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20786806 ↗