EnSite™ ENSITE-SYSTEM-201Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05415067046666), received between Apr 23, 2024 and Apr 23, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unexpected Shutdown” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2024Unexpected Shutdown; Unexpected Shutdown

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, AN UNEXPECTED SHUTDOWN OCCURRED WHICH DELAYED THE PROCEDURE. USING NAVX MODE V3.0.1, WHEN MAPPING, CREATING AND EDITING MODEL, THE SYSTEM BECAME SLOW AND THE DWS SHUT DOWN WITHOUT ANY ALERTS BEING DISPLAYED. AFTER SHUTTING DOWN, THE RED LIGHT ON THE DWS'S POWER BUTTON LIT UP THREE TIMES AND THE BEEP SOUNDED, WHICH OCCURRED REPEATEDLY. THE POWER OUTLET LOCATION WAS CHANGED, AND IT WAS REBOOTED. SINCE IT WAS REBOOTED SUCCESSFULLY, THE PROCEDURE CONTINUED, BUT UNDER THE SAME CIRCUMSTANCES, THIS TIME IT SHUT DOWN WITHOUT SLOWING DOWN. THE DWS REBOOTED BY DISCONNECTING EVERYTHING OTHER THAN THE POWER SUPPLY AND RESTARTING IT, AND THE PROCEDURE CONTINUED. WHEN THE PROCEDURE RESUMED AND RF DELIVERY WAS PERFORMED, IT SHUT DOWN AGAIN. IT WAS REBOOTED A THIRD TIME THE SAME WAY IT WAS THE SECOND TIME. HOWEVER, IT DID NOT REBOOT SO FLUOROSCOPIC IMAGES AND THE RECORDING SYSTEM WERE USED TO CHECK THE LOCATION AND EFFECT OF THE RF DELIVERY. THE PROCEDURE WAS COMPLETED WITHOUT REPLACING THE ENSITE X WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19165098 ↗