CARTO 3 System eco Interface Cable D134402Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10846835022056), received between Mar 27, 2023 and Feb 12, 2026 — classified as 2 malfunctions.

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 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.

• MalfunctionFeb 12, 2026Expiration Date Error

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A CARTO 3 SYSTEM ECO INTERFACE CABLE AND THE DEVICE WAS USED EXPIRED IN SURGERY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24329665 ↗
• MalfunctionMar 27, 2023Signal Artifact/Noise; Communication or Transmission Problem; Signal Artifact/Noise; Communication or Transmission Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A SPLIT HANDLE EXT. CABLE,10' LG AND AN ISSUE WITH BAD/NO ECG ON ALL CHANNELS OCCURRED. IT WAS REPORTED BY THE BIOSENSE WEBSTER INC. (BWI) REPRESENTATIVE THAT THERE WAS NOISE ON ALL ELECTRODES WHEN THE OCTARAY¿ CATHETER WAS CONNECTED TO THE CABLE. THE CABLE WAS REPLACED, AND THE ISSUE WAS RESOLVED, AND THE CASE CONTINUED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. THE ISSUE WITH BAD/NO ECG ON ALL CHANNELS WAS ASSESSED AS A MDR REPORTABLE PRODUCT MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16622891 ↗