EnSite™ ENSITE-TFM-3.1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05415067049711), received between Feb 6, 2025 and Feb 6, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Component Missing” (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 18, 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.

• MalfunctionFeb 6, 2025Component Missing; Component Missing

  DURING AN ABLATION PROCEDURE, IT WAS FOUND THAT THE TACTIFLEX SOFTWARE HAD NOT BEEN INSTALLED RESULTING IN CANCELLATION OF THE PROCEDURE. AFTER CONNECTING THE TACTIFLEX SE, AN ERROR APPEARED THAT THE CATHETER HAD BEEN REUSED OR USED ON ANOTHER PATIENT. THE CATHETER WAS RECONNECTED, A NEW STUDY WAS STARTED, THE SYSTEM WAS REBOOTED, AND THE CATHETER WAS EXCHANGED WITH NO RESOLVE. CUSTOMER SERVICE WAS CALLED, AND THE SOFTWARE WAS CHECKED. IT WAS DISCOVERED THAT THE TACTIFLEX SOFTWARE WAS MISSING. THE PROCEDURE WAS ABORTED AT THIS TIME BECAUSE THE SOFTWARE WAS NOT AVAILABLE AND THERE WAS DIFFICULT PATIENT ANATOMY. ONCE THE DISK WAS OBTAINED, AND THE SOFTWARE WAS INSTALLED THE ISSUE RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21322846 ↗