EnSite™ H421054Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734210546), received between Sep 21, 2018 and Sep 21, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Temperature 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. 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.

• InjurySep 21, 2018Temperature Problem; Temperature Problem

  RELATED MANUFACTURER REPORT NUMBER: 2184149-2018-00158, 9680001-2018-00139, 9680001-2018-00140 . DURING AN ATRIAL FLUTTER ABLATION PROCEDURE, THERE WAS NOISE ON SIGNALS 1 AND 2 OF THE WORKMATE SYSTEM AND THOSE SIGNALS DIDN'T DISPLAY ON THE ENSITE SYSTEM. THE IMPEDANCE VALUE REMAINED AT 999 OHMS AND WOULDN'T COMMUNICATE WITH THE TACTISYS QUARTZ. THE CATHETER WAS REPLACED AND FUNCTIONED AS INTENDED INITIALLY, BUT AFTER A SERIES OF ABLATIONS COMMUNICATION WAS LOST. THE TACTISYS WAS POWER CYCLED SEVERAL TIMES AND COMMUNICATION WAS RESTORED. AFTER THREE MORE ABLATIONS A STEAM POP OCCURRED. THE CATHETER WAS REPLACED TO A NON-ABBOTT CATHETER WITH A NON-ABBOTT GENERATOR. PRIOR TO INSERTING THE CATHETER, THE TEMPERATURE WAS CONFIRMED TO BE HIGH. IT WAS REPLACED AGAIN BUT THE ISSUE REMAINED, SO THE PROCEDURE WAS CANCELLED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7899409 ↗