EnSite™ ENSITE-SW-4.0.1Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05415067053114), received between Nov 21, 2025 and Dec 1, 2025 — classified as 2 malfunctions.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 1, 2025Erratic or Intermittent Display; Erratic or Intermittent Display

  DURING THE PFA PROCEDURE, OUTPUT ISSUES RESULTED IN A PROCEDURAL DELAY. AFTER COLLECTING THE VOLTAGE MAP WITH HD GRID, THE HD GRID WAS WITHDRAWN AND THE NON-ABBOTT PFA CATHETER (FARAWAVE BY BOSTON SCIENTIFIC) WAS INSERTED. CONTACT INDEX BASELINE WAS STARTED AND THE NON-ABBOTT CATHETER (FARAWAVE) PFA CATHETER FLIPPED BACKWARDS IN APPEARANCE EVEN THOUGH IT HAD NOT BEEN PHYSICALLY MOVED. PIN LOCATION WAS CHECKED; THE CATHETER WAS REMOVED FROM ENSITEX AND A NEW ONE WAS LOADED. THE CATHETER PRESETS WERE CHANGED AND RESPIRATORY COMPENSATION WAS PERFORMED WITH NO RESOLUTION. THE AMPLIFIER WAS RESET AND THIS DID NOT FIX THE ISSUE. THE CASE WAS CLOSED; THE AMPLIFIER WAS TURNED OFF AND THE DWS9 COMPUTER WAS REBOOTED. THE CASE WAS RESTARTED; RENDERING WAS APPROPRIATE BUT COULD NOT TAKE SHADOWS OF THE NON-ABBOTT (FARAWAVE) PFA CATHETER. NEXT THE STUDY WAS CLOSED AND THE AMPLIFIER AND DWS9 WERE REBOOTED AGAIN AND STARTED A COMPLETELY NEW CASE WHICH RESOLVED THE ISSUE. RENDERING WAS APPROPRIATE AND ALL TAGS AND MAPPING WORKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23681617 ↗
• MalfunctionNov 21, 2025Display or Visual Feedback Problem; Application Program Freezes or Fails to Launch; Display or Visual Feedback Problem; Application Program Freezes or Fails to Launch

  DURING A PFA PROCEDURE, THERE WAS A SELF-TEST ISSUE WITH THE AMPLIFIER AND SOFTWARE ISSUES RESULTING IN A DELAY. AFTER SETTING UP FOR THE CASE, THE MODE WAS CHANGED FROM VOXEL TO NAVX TO VISUALIZE THE CS AND HIS CATHETERS THAT WERE POSITIONED IN THE HEART UNDER FLUOROSCOPY. THE CATHETERS FROZE AT THE BASE OF THE SCREEN BUT THERE WERE CS AND HIS EGM SIGNALS ON BOTH ENSITE X AND THE NON-ABBOTT (PRUCKA) RECORDING SYSTEM. ADDITIONALLY, WHEN RESPIRATION COMPENSATION WAS PERFORMED, THE FOLLOWING ERROR DISPLAYED, ¿RESPIRATION DATA COLLECTION FAILED. MAY BE CAUSED BY A DAMAGED FIBER CABLE, COMPLEX MODELS, OR RAPID SUCCESSIVE RECORDINGS. RECOLLECT RESPIRATION DATA BEFORE PROCEEDING." THE AMPLIFIER WAS RESTARTED, WHICH RESULTED IN A FLASHING ORANGE LIGHT. THE AMPLIFIER WAS TURNED OFF AGAIN AND THE CASE WAS CLOSED. THE CASE WAS REOPENED AND THE AMPLIFIER TURNED BACK ON, BUT THE FLASHING ORANGE LIGHT REMAINED. EVERYTHING WAS SHUT OFF AND ALL CONNECTIONS TO THE FRONT PANEL OF THE AMPLIFIER WERE RECONNECTED. THE AMPLIFIER WAS THEN TURNED ON AND THE LIGHT WAS GREEN. REVALIDATION WAS PERFORMED, METAL CHECKS WERE DONE AND THE PRS'S WERE GREEN. THE CATHETERS WERE POSITIONED IN THE HEART. THE ADVISOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23618360 ↗