EnSite™ ENSITE-DWS-3.1Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05415067051127), received between Jan 7, 2025 and Aug 27, 2025 — classified as 2 malfunctions.

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. 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.

• MalfunctionAug 27, 2025Communication or Transmission Problem; Communication or Transmission Problem

  DURING THE FLUTTER (RF)/PVI (PFA) PROCEDURE, CONTACT FORCE ISSUES RESULTED IN A PROCEDURAL DELAY. ISSUES WERE NOTED WITH ZEROING CONTACT FORCE. BEFORE THE CATHETER WAS INSERTED IN THE PATIENT, THE CONTACT FORCE COULD BE SET TO ZERO, AND FORCE VALUES ARE PRESENT. UPON INSERTING THE CATHETER THROUGH THE SR0 SHEATH INTO THE PATIENT, CONTACT FORCE COULD NO LONGER BE ZEROED BY EITHER THE PHYSICAL BUTTON ON THE TACTISYS OR WITHIN THE ENSITE GUI. THE ETHERNET CABLE WAS REPLACED, THE RF AND AMPERECONNECT CABLE WAS REPLACED, FOUR TACTIFLEX ABLATION CATHETERS FROM THREE DIFFERENT LOT NUMBERS WERE TRIED, THE SYSTEM WAS REBOOTED, AND THE TACTISYS WAS REPLACED, ALL WITH NO RESOLUTION. THE DWS WAS REPLACED WHICH RESOLVED THE ISSUE AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22904593 ↗
• MalfunctionJan 7, 2025Output Problem; Output Problem

  DURING THE REDO PVI ATRIAL FIBRILLATION ABLATION PROCEDURE, OUTPUT ISSUES RESULTED IN THE PROCEDURE BEING CANCELLED. AFTER THE PATIENT WAS UNDER SEDATION AND THE INTRODUCERS AND NEEDLES WERE PLACED, IT WAS NOTED THAT THERE WAS AN "UNEXPECTED ERROR OCCURRED. APPLICATION EXITED" MESSAGE ON THE DWS WHEN THE CATHETER WAS CONNECTED TO PORT 7 OR 8. THE CATHETER AND CABLES WERE EXCHANGED TWICE, THE CATHETERS WERE IN CONTACT WITH THE PATIENT. THE STUDY WAS REENTERED TWO OR THREE TIMES, WITHOUT RESOLUTION. THE AMPLIFIER AND DWS WERE RESTARTED TWO OR THREE TIMES, WITHOUT RESOLUTION. THE PROCEDURE WAS NOT COMPLETED OR PERFORMED DUE TO THE ISSUE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21091261 ↗