EnSite™ EE3000 (UDI 05415067000910)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05415067000910), received between Sep 3, 2019 and Dec 26, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Communication or Transmission Problem” (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. How this data works · Data updated Oct 13, 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.

• InjuryDec 26, 2019Failure to Power Up; Failure to Power Up

  DURING THE PROCEDURE, THE DWS COMPUTER COULD NOT BOOT TO LOGIN SCREEN. ALL THE USB DEVICES WERE DISCONNECTED WITH NO RESOLUTION. FURTHER TROUBLESHOOTING REVEALED THE ISSUE WAS DUE TO THE DIGITAL CONVERTER. THE PATIENT WAS PREPPED AND THE PROCEDURE WAS CANCELLED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9521611 ↗
• InjurySep 3, 2019Communication or Transmission Problem; Communication or Transmission Problem

  DURING THE PROCEDURE, THE ENSITE SYSTEM WAS OPERATING PROPERLY UNTIL THE CRYOABLATION WAS COMPLETED; HOWEVER, AFTER RF ENERGY WAS DELIVERED FOR AN ATRIAL FLUTTER USING A TACTICATH CATHETER AND THE AMPERE GENERATOR, THE ENSITE DWS BECAME DISCONNECTED FROM THE AMPLIFIER AND NAVIGATION COULD NOT BE PERFORMED AS THE 3-D IMAGES DISAPPEARED. THE POWER SOCKET WAS CHANGED AND THE ENSITE SYSTEM WAS POWER CYCLED WITH NO RESOLUTION. THE RESUME STUDY WAS UNABLE TO BE OPENED. THE PLANNED TREATMENT WAS UNABLE TO BE COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8957369 ↗