EnSite™ ENSITE-PRSFRNT-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05415067033284), received between Apr 5, 2023 and Mar 6, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (2 reports).

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 6, 2025Communication or Transmission Problem; Communication or Transmission Problem

  DURING A CONGENITAL ATRIOVENTRICULAR REENTRANT TACHYCARDIA PROCEDURE, THERE WAS A DELAY DUE TO A COMMUNICATION ISSUE WITH THE PRS CABLES. THE PRS WAS INITIALLY VISIBLE BUT DID NOT STAY VISIBLE. THE SYSTEM WAS REBOOTED, AND THE PRS-A CABLE AND FIELD FRAME WERE BOTH MOVED AND EXCHANGED, BUT THE ISSUE PERSISTED. THE PRS-P CABLE COULD NOT BE MOVED DUE TO GA. THE CASE WAS REVERTED TO NAVX TO SUCCESSFULLY PERFORM THE PROCEDURE WITHOUT ADVERSE CONSEQUENCES. THE PRS SENSORS WERE TESTED AFTER THE PROCEDURE, AND EXCHANGING THE PRS-P CABLE MADE THE SENSORS VISIBLE WITH SOME FLICKERING. EXCHANGING THE PRS-A CABLE MADE SENSORS VISIBLE. BOTH CABLES SEEMED TO CAUSE AN ISSUE AS THE PRS-P CAUSED A SENSOR ISSUE, AND THE PRS-A WOULD INTERMITTENTLY DO THE SAME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21542485 ↗
• MalfunctionApr 5, 2023Communication or Transmission Problem; Communication or Transmission Problem

  DURING DEVICE PREPARATION FOR A PREMATURE VENTRICULAR CONTRACTIONS PROCEDURE, AFTER THE PATIENT WAS PREPPED FOR THE PROCEDURE, IT WAS REPORTED THAT THERE WAS A PRS A NOT CONNECTED MESSAGE RESULTING IN A DELAY. DISCONNECTING, AND RECONNECTING DID NOT RESOLVE THE ISSUE. SWAPPING PORTS DID NOT RESOLVE THE ISSUE EITHER. THE ISSUE WAS THEN RESOLVED BY USING A PRS FROM A DIFFERENT HOSPITAL. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16686677 ↗