EnSite™ ENSITE-ACBL-160-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05415067033376), received between Mar 31, 2026 and Mar 31, 2026 — classified as 1 malfunction.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Communication or Transmission Problem

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE. THERE WAS A PROCEDURAL DELAY. THE POTENTIALS OF ELECTRODES 1-2 DID NOT APPEAR AFTER INSERTION INTO THE PATIENT AND THEY WOULD NOT DISPLAY AS EXPECTED EITHER. ELECTRODES 3-4 WERE NORMAL. THE CABLE AND CATHETER WERE REPLACED WITH NO RESOLUTION. THE PROCEDURE WAS SWITCHED TO NON-ABBOTT MANUFACTURER (JOHNSON & JOHNSON) TO COMPLETE THE PROCEDURE. LATER ON, IT WAS DETERMINED THAT THE ENSITE X AMPERE CONNECT CABLE WAS THE CAUSE OF THE ISSUE RESOLVED AFTER REPLACEMENT. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24745349 ↗