EnSite™ ENSITE-ACBL-60-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05415067033383), received between Aug 14, 2024 and Oct 23, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Connection 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.

• MalfunctionOct 23, 2025Signal Artifact/Noise; Signal Artifact/Noise

  DURING THE SVT PROCEDURE, SIGNAL ISSUES RESULTED IN A DELAY IN PROCEDURE. UPON INSERTION OF THE TACTIFLEX ABLATION CATHETER, IT WAS NOTED THAT ELECTRODE 2 APPEARED DISTORTED. THE CATHETER IN SE PORT 1 WAS UNPLUGGED AND RE-PLUGGED AFTER DELETING THE CATHETER FROM THE CATHETER LIST. THE AMPLIFIER WAS REBOOTED. THE TACTISYS AND THE GREEN TO YELLOW ABLATION CABLE FOR THE TACTIFLEX WERE BOTH REPLACED AND THE AMPERE WAS REBOOTED. ALL CABLES FROM THE TACTISYS WERE DISCONNECTED AND RECONNECTED. THE ISSUE WAS NOT RESOLVED SO THE CATHETER WAS REPLACED WITH NO RESOLUTION. THE AMPERE CONNECT CABLE WAS REPLACED TO RESOLVE THE ISSUE AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23366320 ↗
• MalfunctionAug 14, 2024Connection Problem; Connection Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE AMPERE CONNECT CABLE HAD A CONNECTION ISSUE WHICH RESULTED IN A DELAY TO THE PROCEDURE. THE TACTIFLEX CATHETER WAS PLUGGED IN, BUT IT WAS NOTED THAT IT COULD NOT BE SELECTED AS A ROVING CATHETER ON THE MAPPING SYSTEM. THE CATHETER SETUP SCREEN SHOWED THE CATHETER PLUGGED IN, BUT IT WAS UNABLE TO CONNECT TO THE AMPERE CONNECT PORT. IT WAS ATTEMPTED TO RECONNECT THE CATHETER, AND THEN RESTART THE TACTISYS, AMPERE, ENSITE X AMPLIFIER, AND ENSITE X DWS. ALL PIECES OF EQUIPMENT WERE REGISTERING AS CONNECTED ON THE ENSITE X DWS. IT WAS VERIFIED THAT THE CORRECT TACTISYS CABLE WAS BEING USED TO CONNECT THE TACTISYS TO THE AMPERE. A DIFFERENT TACTIFLEX YELLOW/GREEN CABLE FROM THE TACTISYS TO AMPERE WAS ALSO ATTEMPTED TO BE USED. THEN THE TACTISYS AND AMPERE WERE EXCHANGED FOR SPARE SYSTEMS AT THIS ACCOUNT. AT THIS POINT, IT WAS ATTEMPTED TO REPLACE THE CATHETER, BUT THE REPLACEMENT CATHETER DID NOT RESOLVE THE ISSUE. IT WAS NOTED THAT THE REPLACEMENT CATHETER WAS FROM THE SAME LOT AS THE FIRST, SO IT WAS ATTEMPTED TO OPEN ANOTHER CATHETER FROM A DIFFERENT LOT NUMBER. HOWEVER, THIS ALSO DID NOT RESOLVE THE ISSUE. IT WAS THEN ATTEMPTED TO REPLACE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19983617 ↗