EnSite™ EC1000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05414734215664), received between Sep 20, 2018 and Dec 17, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 16, 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.

• MalfunctionDec 17, 2018Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN ABLATION PROCEDURE, WHEN THE CATHETER WAS INFLATED, A LEAK WAS NOTED IN THE BALLOON. THE TEAR WAS CONFIRMED VIA X-RAY AND THE BALLOON APPEARED DEFLATED. THE ARRAY CATHETER WAS NOT DEFLATED COMPLETELY SO IT COULD HOLD ITS BALLOON INFLATED ENOUGH TO EXECUTE THE PROCEDURE AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8170904 ↗
• MalfunctionSep 20, 2018Use of Device Problem; Use of Device Problem

  DURING A RIGHT VENTRICULAR OUTFLOW TRACT ABLATION, THE EXPIRED CATHETER WOULD NOT DISPLAY A SIGNAL. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7895226 ↗