NA RD128208Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888551045179), received between May 30, 2025 and May 30, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Sense” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionMay 30, 2025Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A REPROCESSED PENTARAY NAV ECO HIGH DENSITY MAPPING CATHETER AND THE CARTO DISPLAYED ERROR 116 (MAGNETIC SENSOR ERROR) FOR THE CATHETER. THE CATHETER CABLE WAS REPLACED, AND THE ISSUE DID NOT RESOLVE. THE CATHETER WAS REPLACED AND THE ISSUE RESOLVED. THIS EVENT WAS ORIGINALLY ASSESSED AS NOT MDR REPORTABLE. THE DEVICE WAS RETURNED FOR ANALYSIS, AND TWO SPINES WERE DAMAGED WITH CABLE EXPOSED. THIS FINDING IS MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22119489 ↗