EnSite™ ENSITE-DWS-2.0.1Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05415067046710), received between Jan 19, 2024 and Dec 5, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  DURING THE RADIOFREQUENCY ATRIAL FIBRILLATION PROCEDURE IN VOXEL MODE, THERE WAS A DELAY DUE TO THE ENSITE DWS LAGGING AND CRASHING. WHILE MAPPING, THE ENSITE X DWS LAGGED AND CRASHED. THE DWS WAS RESTARTED THREE TIMES (EACH RESTART TOOK 15-20 MINUTES), BUT THE LAGGING ISSUE PERSISTED. THE DWS WAS REPLACED, AND THE ISSUE WAS RESOLVED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23735272 ↗
• MalfunctionNov 23, 2025Communication or Transmission Problem; Communication or Transmission 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 23627067 ↗
• MalfunctionJun 4, 2025Communication or Transmission Problem; Communication or Transmission Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, COMMUNICATION ISSUES RESULTED IN A PROCEDURAL DELAY. DIFFICULTY WAS NOTED GETTING COMMUNICATION BETWEEN THE AMPLIFIER AND THE ENSITE X DWS. WHEN THE ENSITE X DWS WAS REBOOTED, IT TOOK A LONGER TIME THAN NORMAL. ONCE BOOTED, AN ATTEMPT WAS MADE TO LOGIN AND THE ENSITE X DWS GAVE A "LOGIN SUCCESSFUL" MESSAGE, BUT DID NOT PROCEED TO THE HOME SCREEN AND INSTEAD STAYED ON THE LOGIN SCREEN BEFORE THE LOGIN PROMPT CAME BACK. THE SYSTEM WAS REBOOTED A TOTAL OF FIVE OR SIX TIMES BEFORE THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22141543 ↗
• MalfunctionMay 27, 2025Application Program Problem; Application Program Problem

  DURING AN ATYPICAL ATRIAL FLUTTER PROCEDURE, FUNCTIONAL ISSUES WITH THE DWS RESULTED IN THE CANCELLATION OF THE PROCEDURE. THE ENSITE X SYSTEM SUDDENLY GOT REALLY SLOW, NOT ANSWERING PROPERLY TO THE CATHETER MOVEMENTS, TAKING LONGER TO RESPOND TO COMMANDS WHEN CLICKING ON BUTTONS, OPENING MENUS, ETC. THE SYSTEM WAS REBOOTED (AMPLIFIER AND DWS), CABLES WERE UNPLUGGED AND PLUGGED, THE CASE WAS CREATED FOR THE SAME PATIENT BUT THE ISSUE REMAINED. THE DWS HARDRIVE HAS ONLY 4 CASES IN IT. THE ISSUE WAS NOT RESOLVED AND THE CASE WAS CANCELLED WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. THE PROCEDURE WILL BE RESCHEDULED FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22090029 ↗
• MalfunctionMay 22, 2025Signal Artifact/Noise; No Apparent Adverse Event; Signal Artifact/Noise; No Apparent Adverse Event

  DUPLICATE OF (B)(4). DURING AN ATRIAL FIBRILLATION PROCEDURE, THERE WAS NOISE DUE TO THE DISPLAY WORKSTATION RESULTING IN CANCELLATION OF THE PROCEDURE. WHEN PREPARING TO START MAPPING WITH THE MAPPING CATHETER, NOISE WAS SEEN IN SOME OF THE EGMS AND THEN ALL THE SIGNALS GOT NOISY WITH INTERFERENCE AND AT TIMES THE EGMS TURNED PURPLE WITH A FLAT LINE. AFTER UNPLUGGING THE MAPPING CATHETER FROM THE AMPLIFIER, THE OTHER CORONARY SINUS SIGNALS RECOVERED. THE MAPPING CATHETER CABLE WAS CHECKED, DISCONNECTED AND CONNECTED AGAIN, AND REPLACED WITH A NEW CABLE BUT THE ISSUE REMAINED. THE AMPLIFIER AND DISPLAY WORKSTATION WERE THEN REBOOTED, AND A NEW CASE WAS STARTED, AND THE MAPPING CATHETER WAS EXCHANGED BUT THE ISSUE REMAINED. ALL THE TROUBLESHOOTING WAS REPEATED WITHOUT SUCCESS. A THIRD CATHETER, THIS TIME AN ADVISOR HD GRID RATHER THAN AN ADVISOR HD GRID X WAS USED. HOWEVER, THE ISSUE STILL DID NOT RESOLVE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22073367 ↗
• MalfunctionJan 23, 2025Communication or Transmission Problem; Communication or Transmission Problem

  DURING AN ATRIAL TACHYCARDIA PROCEDURE, COMMUNICATION ISSUES RESULTED IN A PROCEDURAL DELAY. WHILE WORKING IN VOXEL MODE, THE ABLATION CATHETER WAS NO LONGER DISPLAYED. ALL THE CABLES WERE CHECK AND RECONNECTED. THE CATHETER WAS REPLACED WITH NO RESOLUTION. THE DWS WAS RESTARTED AND THE STUDY WAS RESUMED WHICH RESOLVED THE ISSUE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21217400 ↗
• MalfunctionDec 5, 2024Power Problem; Power Problem

  BEFORE AN ATRIAL FIBRILLATION PROCEDURE, WHILE PATIENT WAS PREPPED, IT WAS NOT POSSIBLE TO TURN ON THE ENSITE X DISPLAY WORKSTATION RESULTING IN A DELAY. THE DWS WAS RESTARTED 3 TIMES, BUT IT WOULD NOT POWER UP. A MESSAGE "THE SYSTEM TIME IS INVALID. THIS MAY BE A RESULT OF A LOSS IN BATTERY POWER" APPEARED. THE DWS WAS EXCHANGED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20854505 ↗
• MalfunctionJan 19, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS CONFIRMED THAT THIS ISSUE WAS RESOLVED BY REPLACING THE PRS SENSOR. THE DWS IS STILL IN USE IN THE FIELD WITHOUT REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18543083 ↗