EnSite™ ENSITE-SW-3.0.2Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05415067050014), received between Aug 8, 2024 and Mar 31, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Application Program Version or Upgrade 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.

• MalfunctionMar 31, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  DURING THE SUPRAVENTRICULAR TACHYCARDIA PROCEDURE USING ENSITEX V3.0.2, DISPLAY ISSUES RESULTED IN A PROCEDURAL DELAY. IT WAS NOTED THAT SE POINTS COULD NOT BE COLLECTED. THE CATHETER SHOWED GREEN ON ENSITE GUI AND THE CATHETER WAS OUT OF THE SHEATH. TROUBLESHOOTING INCLUDED TRYING A DIFFERENT SE POINT, REPLACING THE CATHETER, RESTARTING THE SYSTEM, AND RESTARTING THE STUDY ALL WITH NO RESOLUTION. THE SE CABLE WAS RECONNECTED, THE CATHETERS WERE DELETED AND AUTO-POPULATED, THE SE CABLE WAS MOVED TO THE SE2 PORT ON THE AMPLIFIER, THE DWS WAS RECONNECTED TO THE AMPLIFIER VIA SOFTWARE, AND THE AMPLIFIER WAS POWER CYCLED, ALL WITH NO RESOLUTION. SWITCHED TO VOXEL MODE AND CONFIRMED VOXEL/GEO CREATION WITH THE ABLATION CATHETER AND RETURNED TO NAVX MODE WHICH RESOLVED THE ISSUE. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21730000 ↗
• MalfunctionAug 8, 2024Application Program Version or Upgrade Problem; Application Program Version or Upgrade Problem

  DURING CATHETER SET UP FOR ABLATION OF A SLOW PATHWAY, THE SE PORTION OF THE ABLATION CATHETER WAS NOT RECOGNIZED BY THE ENSITE AMPLIFIER WHICH CAUSED A DELAY IN PROCEDURE. THE CATHETER WAS DISCONNECTED AND RECONNECTED, THE SYSTEM WAS RESTARTED, AND PRESETS WERE REMOVED; HOWEVER, THE ISSUE PERSISTED. THE CATHETER WAS REPLACED WITH ANOTHER TACTIFLEX WITH A DIFFERENT LOT NUMBER WHICH DID NOT RESOLVE THE ISSUE. A NON-ABBOTT (BIOSENSE WEBSTER CELSIUS) ABLATION CATHETER WAS USED TO COMPLETE THE PROCEDURE WITHOUT CONSEQUENCE. THE ISSUE WAS DETERMINED TO BE DUE TO NOT LOADING THE ENSITE-TFM-3.0.2 SOFTWARE DURING THE RECENT SOFTWARE UPGRADE FOR PFA VISUALIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19940126 ↗