Carto 3 CB3410CTRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10846835003789), received between Sep 12, 2021 and Sep 12, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K090017); they may or may not involve this specific model.

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

• MalfunctionSep 12, 2021Product Quality Problem; Contamination /Decontamination Problem; Product Quality Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT AN UNKNOWN PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A CARTO® 3 SYSTEM INTERFACE CABLE. THERE WAS DIRT IN THE PACKAGE. WHEN REMOVING THE MATERIAL FROM THE BOX (EXTERNAL PACKAGING), IT WAS OBSERVED THAT THE MATERIAL ITSELF HAD A DIRT COMPARED TO THE PAINT, BEING CONSIDERED AS CONTAMINATED. THE (TRANSPARENT) INNER PACKAGING WAS INTACT AND WAS NOT OPENED FOR CORRECT ANALYSIS OF WHAT HAPPENED. I EMPHASIZE THAT THE "INK" WAS IN THE MATERIAL, AND THE INNER PACKAGING HAD NOT BEEN BROKEN. NO PATIENT CONSEQUENCES. COSMETIC DAMAGE IS NOT MDR-REPORTABLE. FOREIGN MATERIAL INSIDE OF THE PACKAGING IS MDR-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12457949 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K090017. One submission often covers many models, so check the product and lot details in each record.

• Z-1230-2012 · Feb 9, 2012 · Terminated
  CARTO 3 Systems, Product Code M-4800-01 The intended use of the CARTO 3 System is catheter-based cardiac electrophysiological (EP) procedures.
• Z-1839-2011 · Feb 15, 2011 · Terminated
  10 ft. Interface Cable, 10 Pin - Shielded Tip Pins to 12 Pin - Blue, Manufacturing Part Number 01287-09, Catalog Number D128709. This cable is used to connect an Auto 10 10-pole ca
• Z-0884-2011 · Oct 5, 2010 · Terminated
  CARTO 3 System Interface Cable, 34-pin to 10-pin, Red, 10' - Part Number: D-1286-18; Catalog Number CR3410CT This product provides a signal interface between a Biosense Webster ele
• Z-2369-2012 · Nov 17, 2009 · Terminated
  CARTO 3 V1.05(FG-5400-00). The CARTO 3 V1.05 System is intended for catheter-based atrial and ventricular mapping. The mapping system allows real-time display of cardiac maps in a