EnSite™ ENSITE-SW-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05415067047854), received between Oct 25, 2023 and Sep 16, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Application Program 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 18, 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.

• MalfunctionSep 16, 2024Application Program Problem; Application Program Problem

  RELATED MANUFACTURING REFERENCE: 3008452825-2024-00522. DURING THE SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, COMMUNICATION ISSUES RESULTED IN A PROCEDURAL DELAY. WHILE USING ENSITE X V3.0.1 IN VOXEL MODE, A TACTICATH SE WAS CONNECTED TO THE ENSITE X AMPLIFIER WITH AN SE CABLE TO SE1 OR SE2 ON THE AMPLIFIER, AND THE SYSTEM IMMEDIATELY DISPLAYED, "UNEXPECTED ERROR" AND THE STUDY WAS AUTOMATICALLY CLOSED. THE AMPLIFIER, DWS, AND TACTISYS WERE ALL RESTARTED BUT THE ISSUE WAS NOT RESOLVED. THE CATHETER WAS REPLACED BUT THE ISSUE PERSISTED. THE PROCEDURE WAS COMPLETED USING THE SECOND CATHETER IN NAVX MODE AND WITHOUT CONNECTING THE SE CABLE OF THE CATHETER TO THE AMPLIFIER, WITHOUT MAGNETIC NAVIGATION. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20229986 ↗
• MalfunctionOct 25, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, A SHIFT OCCURRED RESULTING IN CANCELLATION OF THE PROCEDURE. THERE WAS A SHIFT IN ENSITEX IN VOXEL MODE; ALIGNMENT COULD NOT BE DONE AND COULD NOT COMPENSATE THE SHIFT. PRS-A AND PRS-P SENSORS WERE CORRECTLY PLACED AND RESPIRATION WAS DONE MULTIPLE TIMES WHICH DID NOT RESOLVE THE ISSUE AND THE PROCEDURE WAS CANCELLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18003158 ↗