EnSite™ ENSITE-DWS-04Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05415067051257), received between Feb 6, 2026 and Aug 17, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (5 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 16, 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.

• MalfunctionAug 17, 2026Output Problem

  During an atrial fibrillation procedure, after patches were placed on the patient, an attempt was made to create a new study using an existing patient record. At that time, the system displayed an "unexpected error" message, and the study could not be created. The EnSite X DWS was exchanged with a replacement system, resulting in a procedural delay. Following replacement of the DWS, the procedure was completed successfully with no adverse patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50287646 ↗
• MalfunctionMar 31, 2026Application Program Problem; Application Program Freezes or Fails to Launch

  DURING THE RADIOFREQUENCY ABLATION SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THERE WAS A PROCEDURAL DELAY. IT WAS NOTED THAT THE ENSITE X SYSTEM WAS "FREEZING". IT WAS NOTED THAT THE MOUSE WAS ABLE TO MOVE, BUT WAS UNABLE TO CLICK ANY MENUS, WINDOWS, OR FUNCTIONS. TROUBLESHOOTING INCLUDED REBOOTING THE ENSITE X SYSTEM AND REPLACING THE ENSITE X DWS, WHICH RESOLVED THE ISSUE. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24744659 ↗
• MalfunctionFeb 25, 2026Communication or Transmission Problem

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THE PROCEDURE WAS ABORTED. VALIDATION COULD NOT BE PERFORMED. A LEFT ARM AND LEFT LEG ERROR, ALONG WITH SYSTEM REFERENCE PATCH ERRORS WERE DISPLAYED. THE PATCHES WERE EXCHANGED, AND THE AMPLIFIER AND DWS WERE REBOOTED TWICE. THREE NEW STUDIES WERE STARTED, THE SURFACELINK WAS RESEATED, AND PATCHES WERE RESEATED INTO THE SURFACELINK. THE SURFACELINK WAS EXCHANGED WITH NO RESOLUTION. THE PROCEDURE WAS ABORTED, AND NO PROCEDURE WAS PERFORMED (NOT EVEN GROIN ACCESS). THOUGH THE PATIENT HAD BEEN UNDER ANESTHESIA. FURTHER TROUBLESHOOTING AT A LATER DATE DETERMINED THAT THE ISSUE WAS THE DWS WHICH HAS BEEN SINCE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24445116 ↗
• MalfunctionFeb 11, 2026Communication or Transmission Problem

  DURING AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA PROCEDURE THERE WAS A DELAY. THE PROCEDURE WAS STARTED WITH ENSITEX DWS 9 (V5.0.1) AND HIS, CR, AND HRA CATHETERS WERE INSERTED IN THE PATIENT. ALL THE CATHETERS APPEARED ELONGATED AND STACKED ON EACH OTHER. THOUGH THE EGMS AND SURFACE SIGNALS WERE FINE. THE SYSTEM WAS REBOOTED WITH NO RESOLUTION. A NEW CASE WAS STARTED BUT AN AMPLIFIER ISSUE OCCURRED AND TECH SUPPORT WAS CALLED. EVERYTHING HAD TO BE DISCONNECTED FROM THE AMPLIFIER TO GET IT TO BOOT UP CORRECTLY. AFTER THAT, THERE WERE SEVERAL IMPEDANCE ERRORS AND GEOGRAPHY COULD NOT BE COLLECTED. THE CATHETERS WERE UNABLE TO SHOW OR WERE DISTORTED. THE NAVX PATCHES WERE REPLACED WITH NO RESOLUTION. A TACTIFLEX CATHETER WAS USED BUT THE SAME ISSUE OCCURRED WITH THE CATHETER APPEARING DISTORTED IN NAVX. IN VOXEL MODE, THE SE GUMBALL KEPT HAVING "INVALID SHAFT ELECTRODE DATA" AND "POOR IMPEDANCE DATA" ERRORS. SHADOWS WERE DROPPED, AND THE FORCE ARROW WAS WORKING AS EXPECTED BUT COULD NOT COLLECT DATA. THE PROCEDURE WAS COMPLETED WITH USING FLUOROSCOPY AND SIGNALS. FURTHER TROUBLESHOOTING AT A LATER DATE DETERMINED THAT THE ISSUE WAS THE DWS WHICH HAS BEEN SINCE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24315139 ↗
• MalfunctionFeb 6, 2026Application Program Freezes or Fails to Launch

  DURING A PFA PROCEDURE, THERE WAS A DELAY DUE TO A COMMUNICATION AND SELF-TEST ISSUE WITH THE AMPLIFIER AND A FREEZING ISSUE WITH THE DISPLAY WORKSTATION. THE AMPLIFIER DISCONNECTED AND DISPLAYED AN AMBER LIGHT. THERE WERE ABOUT 10 REBOOTS OF THE AMPLIFIER AND 2-3 REBOOTS OF THE DISPLAY WORKSTATION WHILE THE PATIENT WAS ON THE TABLE WITH CORRECT BOOT UP SEQUENCE BEFORE THE CASE COULD BE STARTED. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24275397 ↗
• MalfunctionFeb 6, 2026Application Program Freezes or Fails to Launch

  DURING A PFA PROCEDURE, THERE WAS A DELAY DUE TO A COMMUNICATION AND SELF-TEST ISSUE WITH THE AMPLIFIER AND A FREEZING ISSUE WITH THE DISPLAY WORKSTATION. THE AMPLIFIER DISCONNECTED AND DISPLAYED AN AMBER LIGHT. THERE WERE ABOUT 10 REBOOTS OF THE AMPLIFIER AND 2-3 REBOOTS OF THE DISPLAY WORKSTATION WHILE THE PATIENT WAS ON THE TABLE WITH CORRECT BOOT UP SEQUENCE BEFORE THE CASE COULD BE STARTED. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24275390 ↗
• MalfunctionFeb 6, 2026Application Program Freezes or Fails to Launch

  DURING A PFA PROCEDURE, THERE WAS A DELAY DUE TO A COMMUNICATION AND SELF-TEST ISSUE WITH THE AMPLIFIER AND A FREEZING ISSUE WITH THE DISPLAY WORKSTATION. THE AMPLIFIER DISCONNECTED AND DISPLAYED AN AMBER LIGHT. THERE WERE ABOUT 10 REBOOTS OF THE AMPLIFIER AND 2-3 REBOOTS OF THE DISPLAY WORKSTATION WHILE THE PATIENT WAS ON THE TABLE WITH CORRECT BOOT UP SEQUENCE BEFORE THE CASE COULD BE STARTED. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24275384 ↗
• MalfunctionFeb 6, 2026Application Program Freezes or Fails to Launch

  DURING A PFA PROCEDURE, THERE WAS A DELAY DUE TO A COMMUNICATION AND SELF-TEST ISSUE WITH THE AMPLIFIER AND A FREEZING ISSUE WITH THE DISPLAY WORKSTATION. THE AMPLIFIER DISCONNECTED MID APPLICATION OF PFA. THE AMPLIFIER DISPLAYED AN AMBER LIGHT. THE SYSTEM WAS REBOOTED WITH EVERYTHING DISCONNECTED. THE CATHETER WOULD THEN NOT VISUALIZE ON ENSITE AND FROZE REQUIRING LOGGING OUT OF THE SYSTEM. THERE WAS AN INTERNAL "RECONNECT TO PFA GENERATOR" WHEN THE VOLT ICON WAS STILL GREEN AND "RECONNECT TO SE SYSTEM" ERROR. THE CURRENT PFA GENERATOR OPTIONS WERE GREYED OUT AND DESPITE RESTARTING THE CURRENT PFA GENERATOR THERE WAS NO RESOLUTION. THE CASE WAS EXITED AND RELOADED, BUT IT WAS NOT POSSIBLE TO RESUME THE CASE. THE PROCEDURE WAS COMPLETED WITHOUT ENSITE USING X-RAY AND WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24275381 ↗