EnSite™ ENSITE-DWS-1.1Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 05415067037725), received between Jun 16, 2022 and Mar 27, 2025 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (8 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 27, 2025Communication or Transmission Problem; Communication or Transmission Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, A COMMUNICATION ISSUED OCCURRED CAUSING A DELAY. THE ENSITE X WAS USED WITH FARAWAVE NAVX MODE, AND COMMUNICATION BETWEEN THE AMPLIFIER AND DWS WAS INTERRUPTED TOWARD THE END OF POST MAPPING AFTER PULSE FIELD ABLATION. A "COMMUNICATION FAILURE" ALERT POP-UP WAS DISPLAYED, AND THE ELECTRIC POTENTIAL WAVEFORM BECAME PURPLE FLAT. AMPLIFIER RECONNECT AND RESET AMPLIFIER WERE PERFORMED FROM THE DWS SIDE, BUT THE ALERT PERSISTED. DURING THAT TIME, THE LAMP NEXT TO THE AMPLIFIER POWER BUTTON WAS FLASHING GREEN, AND THE LAMP AT THE OPTICAL CABLE PORT ON THE DWS WAS NOT LIT. THE LAMP ON THE AMPLIFIER SIDE WAS LIT ORANGE. THE OPTICAL CABLE WAS EXCHANGED, THE CABLES ON THE PANELS OF THE AMPLIFIER WERE REMOVED AND THE POWER OF DWS AND AMPLIFIER WERE TURNED OFF. THE DWS WAS THEN STARTED UP, AND THE AMPLIFIER WAS STARTED UP AS PER PROPER INSTRUCTIONS, BUT COMMUNICATION WAS NOT RESTORED. THE AMPLIFIER POWER LAMP WAS FLASHING GREEN AND THE DWS OPTICAL CABLE LAMP REMAINED OFF. DWS RESTART WAS PERFORMED 4 TIMES, BUT COMMUNICATION WAS NOT RESTORED. THEREFORE, IT WAS NOT POSSIBLE TO CONTINUE NAVIGATION USING ENSITE, AND IT WAS SWITCHED TO ABLATION UNDER FLUOROS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21710425 ↗
• MalfunctionMar 5, 2025Application Program Problem; Application Program Problem

  DURING A PROCEDURE, THERE WERE REPETITIVE ENSITE X SYSTEM FREEZES WITH NO APPARENT CAUSE RESULTING IN CANCELLATION OF THE PROCEDURE. THE SYSTEM WAS REBOOTED MULTIPLE TIMES, AND EACH TIME THE SYSTEM WOULD FREEZE AT DIFFERENT POINTS WITHIN A FEW MINUTES. THE AMPLIFIER WAS DISCONNECTED FROM THE DISPLAY WORKSTATION AND THE SYSTEM FROZE ON THE ABBOTT LOADING LOGO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21529161 ↗
• MalfunctionMar 4, 2025Output Problem; Output Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THERE WAS AN ERROR ON THE DISPLAY WORKSTATION RESULTING IN A DELAY. THE DWS BOOTED UP WITH A MESSAGE REQUIRING A LUKS PASSWORD AND ASKING FOR THE USER TO REMOVE ANY USB DEVICE. THE POWER CORD WAS UNPLUGGED, A DIFFERENT OUTLET WAS TRIED, AND 6-8 REBOOTS WERE PERFORMED WITH DIFFERENT CONFIGURATIONS OF EQUIPMENT PLUGGED INTO THE AMPLIFIER WERE ATTEMPTED, BUT THE ISSUE WAS NOT RESOLVED. THE DWS WAS REPLACED, AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21511925 ↗
• MalfunctionJan 19, 2025Communication or Transmission Problem; Communication or Transmission Problem

  DURING THE ATRIAL FIBRILLATION PROCEDURE WITH ENSITE X, THE SCREEN SUDDENLY FROZE AND A FORCED SHUTDOWN OCCURRED. THERE WAS AN ISSUE THAT THE CONNECTION BETWEEN AMP AND ENSITE X SUDDENLY DROPPED, AND THE OPTICAL CABLE WAS REPLACED WITH NO RESOLUTION. AFTER RESTARTING, THE SAME ISSUE REOCCURRED AFTER ABOUT 5-10 MINUTES. THE POWER SOURCE WAS CHANGED, AND UNNECESSARY CATHETERS WERE REMOVED FROM THE CATHETER PRESET, WITH NO RESOLUTION. THE SAME ERROR PERSISTS EVEN AFTER MULTIPLE REBOOTS. FORCED SHUTDOWN OCCURRED APPROXIMATELY SIX TIMES IN ONE PROCEDURE. THE PROCEDURE WAS COMPLETED WITHOUT REPLACING THE ENSITE X DWS AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NEITHER DEVICE HAS BEEN USED SINCE THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21188280 ↗
• MalfunctionDec 10, 2024Communication or Transmission Problem; Communication or Transmission Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, A COMMUNICATION ISSUE OCCURRED CAUSING A PROCEDURE DELAY. IT WAS NOT POSSIBLE TO CONNECT THE DWS WITH THE AMPLIFIER (THE LIGHT WAS FLASHING IN GREEN). THREE DIFFERENT FIBER OPTIC CABLES WERE TRIED WITH NO RESOLUTION. THE SYSTEM WAS THEN RESTARTED SEVERAL TIMES WHICH DID NOT RESOLVE THE ISSUE. THE ISSUE WAS SOLVED BY USING THE OTHER FIBER OPTIC OUTPUT OF THE ENSITE X DWS (THE ONE ON THE LEFT). THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20893086 ↗
• MalfunctionApr 11, 2024Output Problem; Output Problem

  DURING PREPARATION FOR A PULMONARY VEIN ISOLATION PROCEDURE WITH THE PATIENT ON THE TABLE, AN ERROR MESSAGE WAS NOTED WHICH DELAYED THE PROCEDURE. THEE DWS STATED THE REAR CHASSIS FAN WAS NOT DETECTED. THE DWS WAS REBOOTED APPROXIMATELY FIVE TIMES TIMES, WHICH RESOLVED THE ISSUE AND THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19088914 ↗
• MalfunctionMar 12, 2024Communication or Transmission Problem; Communication or Transmission Problem

  DURING THE ATRIAL FIBRILLATION PROCEDURE, COMMUNICATION ISSUES RESULTED IN THE PROCEDURE BEING CANCELLED. AFTER THE ENSITE DWS WAS PHYSICALLY CONNECTED TO THE HOSPITAL NETWORK CABLE BUT THE AMPLIFIER WOULD NOT CONNECT. THE CABLE WAS DISCONNECTED, BOTH THE AMPLIFIER AND DWS WERE REBOOTED, AND THE FIBER OPTIC CABLE WAS REPLACED, ALL WITHOUT RESOLVING THE ISSUE. THE ANATOMICAL MAPPING AND ABLATION COULD NOT BE PERFORMED AND THE PROCEDURE WAS CANCELLED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES RESULTING FROM THE CANCELLATION. THE PROCEDURE HAS NOT YET BEEN RESCHEDULED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18890908 ↗
• MalfunctionFeb 13, 2024Communication or Transmission Problem; Communication or Transmission Problem

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THE ENSITE X AMPLIFIER WAS NOT COMMUNICATING WITH THE ENSITE X DISPLAY WORKSTATION RESULTING IN CANCELLATION OF THE PROCEDURE. A SECOND NEW FIBER WAS ATTEMPTED, RESTARTED THE SYSTEM, RESEATED THE SFP CONNECTIONS, DISCONNECTED THE ETHERNET DATA PORT WITH NO RESOLVE. THE ENSITE X AMPLIFIER WAS REPLACED, BUT THERE WAS STILL NO COMMUNICATION. THE SFP WERE EXCHANGED WITH A SECOND AMPLIFIER, BUT THE ISSUE WAS NOT RESOLVED. THE ENSITE X DISPLAY WORKSTATION WAS THEN ALLEGED TO BE THE ISSUE. THE CASE WAS CANCELLED WITH A PATIENT ON THE TABLE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18698059 ↗
• MalfunctionNov 13, 2023Communication or Transmission Problem; Communication or Transmission Problem

  DURING AN ATRIAL TACHYCARDIA PROCEDURE, THE MAGNETIC SENSOR OF THE CATHETER DID NOT RESPOND INTERMITTENTLY AND WAS NOT STABLE RESULTING IN A DELAY. THE CABLE AND CATHETER WERE EXCHANGED WITH NO RESOLUTION, BUT THE ISSUE WAS RESOLVED BY RESTARTING THE SYSTEM. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18117586 ↗
• MalfunctionSep 26, 2023Output Problem; Output Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THERE WAS NOT OUTPUT FROM THE REMOTE VIDEO AND THE PROCEDURE WAS CANCELLED. THE DWS WAS REBOOTED WHICH RESTORED REMOTE VIDEO, BUT THEN THERE WERE AMPLIFIER COMMUNICATION ISSUES. AFTER RESTARTING BOTH THE DWS AND AMPLIFIER SEVERAL TIMES, COMMUNICATION WAS NOT ESTABLISHED, AND THE CASE WAS CANCELLED. THE PATIENT WAS RESCHEDULED FOR OCT. 6. THE DEVICE IS STILL BEING USED AT THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17816384 ↗
• MalfunctionSep 12, 2023Communication or Transmission Problem; Communication or Transmission Problem

  THIS REPORT IS TO PROVIDE THE ANALYSIS OF THE DEVICE AND TO INCLUDE THE CORRECTED DEVICE INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17728532 ↗
• MalfunctionSep 11, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  DURING AN EPICARDIAL VENTRICULAR TACHYCARDIA ABLATION, IN A PATIENT WITH AN IMPLANTED SICD, THERE WAS A DELAY DUE TO MAPPING ISSUES WITH THE ENSITE X SYSTEM. THERE WERE CATHETER LOCATION ISSUES, BUT THE PATCH VALIDATION WAS OKAY, AND THE CHECK METAL FIELD AND METAL BASELINE WERE OKAY. IT WAS NOT POSSIBLE TO COLLECT GEOMETRY WITH THE ELECTRODES OF THE ADVISOR HD GRID MAPPING CATHETER. ACQUISITION WAS ONLY POSSIBLE WITH THE CATHETER SHAFT AND ACTIVATION POINTS WERE UNABLE TO BE TAKEN BECAUSE THE ADVISOR HD GRID MAPPING CATHETER WAS IN NO LOCATION. THE KT WAS MOVED IN VARIOUS DIRECTIONS WITH NO RESOLUTION. THE PATCHES WERE CHECKED, THE ADVISOR HD GRID MAPPING CATHETER AND CABLE WERE CHANGED, AS WELL AS THE REFERENCE PATCH. THE AMPLIFIER WAS TURNED OFF AND ALL CABLES WERE DISCONNECTED FROM IT AND 20 SECONDS WERE PLUGGED BACK IN AND THE AMPLIFIER WAS TURNED BACK ON, BUT THE ISSUE PERSISTED. THE PROCEDURE WAS FINALLY PERFORMED IN NAVX MODE WITH NO ADVERSE PATIENT CONSEQUENCES. THE PROCEDURE WAS LENGTHENED BY ONE HOUR DUE TO TECHNICAL ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17726623 ↗
• MalfunctionAug 9, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  DURING AN ATRIAL FLUTTER PROCEDURE, DISPLAY ISSUES RESULTED IN THE PROCEDURE BEING CANCELLED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. IT WAS NOTED THAT THE MAPPING AND THE CARDIAC CYCLE LENGTH FAILED, THE DATA COLLECTED WAS OUTSIDE OF THE SET CARDIAC CYCLE LENGTH PARAMETERS WHICH AFFECTED THE FIDELITY OF THE MAP AS IT ADDED ERRONEOUS DATA TO THE MAP. FREEZING AND SAVING A NEW TEMPLATE AGAIN RESOLVED THE ISSUE BUT THE PROCEDURE WAS CANCELLED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17487491 ↗
• MalfunctionMay 15, 2023Signal Artifact/Noise; Signal Artifact/Noise

  DURING THE PREMATURE VENTRICULAR CONTRACTION PROCEDURE, NOISE ISSUES RESULTED IN PROCEDURAL DELAYS. THE DISPLAY WORKSTATION AND THE AMPLIFIER WERE REBOOTED TO RESOLVE THE ISSUE AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. MAPPING WAS COMPLETED WITH THE MAPPING CATHETER. THE ABLATION CATHETER WAS DISPLAYED ON THE MONITOR, THE CONTACT FORCE WAS DISPLAYED NORMALLY, THE ELECTRIC POTENTIAL WAS DISPLAYED ON THE RECORDING SYSTEM, BUT IT WAS NOT DISPLAYED ON THE ENSITE SIDE. ROVING COULD BE SELECTED BUT WAVEFORM SENSING WAS NOT POSSIBLE, AND POINTS COULD NOT BE ACQUIRED. THE CABLE WAS REINSERTED WITH NO RESOLUTION. THE CATHETER WAS REPLACED ANOTHER ABLATION CATHETER WITH NO RESOLUTION. THE SECOND CATHETER WAS REPLACED, BUT THE ISSUE PERSISTED. THE DISPLAY WORKSTATION AND THE AMPLIFIER WERE REBOOTED AND 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 16930160 ↗
• MalfunctionMay 8, 2023Signal Artifact/Noise; Signal Artifact/Noise

  RELATED MANUFACTURING REFERENCE: 2184149-2023-00098. DURING THE VENTRICULAR TACHYCARDIA ABLATION PROCEDURE, SIGNAL NOISE ISSUES RESULTED IN THE PROCEDURE BEING CANCELLED. IT WAS NOTED THAT THERE WAS A LOSS OF BOTH SURFACE AND INTRACARDIAC SIGNALS, THE CATHETERS WERE FROZEN ON THE SCREEN BUT THE LIVE IMPEDANCE NUMBERS WERE STILL CHANGING. IT WAS POSSIBLE TO MOVE THROUGH THE TABS AND MENUS WITHOUT PROBLEMS AND LOAD THE DIFFERENT SAVED MAPS - SUGGESTING THE SYSTEM WAS NOT FROZEN. THE BACKGROUND OF THE WAVEFORM WINDOW TURNED BLUE AND THE ELECTROGRAM LINES TURNED PURPLE. THERE WERE NO ERROR MESSAGES GIVEN FROM THE SYSTEM AND THE LIGHT ON THE FRONT OF THE ENSITE X AMPLIFIER STAYED SOLID GREEN. REPLACING THE RIGHT LEG LEAD, SURFACE REFERENCE, AND SURFACELINK DID NOT RESOLVE THE ISSUE. REBOOTING THE AMPLIFIER AND DWS RESTORED THE SIGNALS, HOWEVER THE PROCEDURE WAS ALREADY ABORTED AND HAS NOT BEEN RESCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16886760 ↗
• MalfunctionFeb 16, 2023Communication or Transmission Problem; Communication or Transmission Problem

  DURING A WOLFF-PARKINSON-WHITE PROCEDURE WHILE USING THE ENSITE X SYSTEM IN VOXEL MODE THERE WAS A SUDDEN LOSS OF COMMUNICATION BETWEEN DISPLAY WORKSTATION, AMPERE, AND AMPLIFIER THAT RESULTED IN CANCELLATION OF THE PROCEDURE. THE ECG AND EGM SIGNALS WERE LOST DUE TO THE COMMUNICATION ISSUE. AFTER A FEW MINUTES THE PROCEDURE HAD TO BE STOPPED AS COMMUNICATION COULD NOT BE RESTORED. ONCE THE PATIENT LEFT, THE LAB REBOOTED THE SYSTEM WITH NO SUCCESS. ON A SECOND ATTEMPT EVERYTHING WAS TURNED OFF, DISCONNECTED FROM THE MAINS AND THEN LEFT OFF FOR A FEW MINUTES. ONCE THE SYSTEM WAS TURNED ON THE CONNECTION WAS RESTORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16393478 ↗
• MalfunctionJun 16, 2022Impedance Problem; Impedance Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, AN IMPEDANCE ISSUE OCCURRED AND THE PROCEDURE WAS CANCELLED. WHEN ATTEMPTING TO ABLATE THE CAVOTRICUSPID ISTHMUS CTI WITHOUT ANATOMY (JUST WITH THE HELP OF THE CS CATHETER), 0W DISPLAYED ON THE GENERATOR SEVERAL TIMES AND THE IMPEDANCE ROSE TO 999. THE AMPERE GENERATOR HAD TO BE RESTARTED TWICE, GROUNDED, AND A SECOND NEUTRAL ELECTRODE HAD TO BE USED. A LOOSE CONTACT WAS ALSO NOTICED ON THE FLEXABILITY. THE PROCEDURE WAS MORE COMPLEX THAN EXPECTED, AND SEVERAL MAPS AND HAD TO BE CARRIED OUT. THE PATIENT BECAME RESTLESS OVER TIME. THE SYSTEM DISPLAYED SEVERAL WARNINGS, INCLUDING "VOXEL COLLECTION IS SUSPENDED BECAUSE THE SYSTEM HAS DETECTED AN IMPEDANCE SHIFT. EXISTING VOXELS WERE DELETED TO RESOLVE THE ISSUE. THEN, THE FIELD FRAME DISCONNECTED AND COULD NOT BE RECONNECTED. THE NECK PATCH ALSO SHOWED AS DISCONNECTED. THE PHYSICIAN DID NOT WANT TO VALIDATE THE EXAMINATION AGAIN OR CARRY OUT FURTHER TROUBLESHOOTING. THE PROCEDURE HAD TO BE STOPPED BECAUSE THE ANATOMICAL POSITION WAS NOT REACHED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. IT IS SUSPECTED THE ISSUE WAS THE PATIENT'S FAULT AS NO SIMILAR PROBLEMS HAVE OCCURRED SINCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14712760 ↗