Carto 3 CB3412CTRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10846835003796), received between Jun 5, 2023 and Jun 5, 2023 — 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.

• MalfunctionJun 5, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER RIGHT (R-AFL) PROCEDURE WITH A CARTO® 3 SYSTEM INTERFACE CABLE AND FOREIGN MATERIAL INSIDE THE PACKAGING OUTSIDE OF SPECIFICATION ISSUE OCCURRED. THERE WAS A TINY PIECE OF CARDBOARD INSIDE THE STERILE PACKAGING OF THE CARTO® 3 SYSTEM INTERFACE CABLE. THE CARTO® 3 SYSTEM INTERFACE CABLE WAS REPLACED AND THE ISSUE RESOLVED. THE PROCEDURE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THE ISSUE WAS OBSERVED PRIOR TO THE PRODUCT BEING USED. THE CABLE WAS PACKAGED AND SENT FOR RETURN BEFORE THE FOLLOW-UP EMAIL GOT TO THE CALLER. THEREFORE, THE BOX WAS NOT SENT. THE CABLE IN THE ORIGINAL PACKAGING WAS RETURNED AND HAS NOT BEEN OPENED. THE FOREIGN OBJECT IS STILL IN PACKAGING UNTOUCHED. THE CALLER DID NOT TAKE PHOTOS AND THE PRODUCT WAS ALREADY PACKAGED FOR RETURN. THE OBJECT IS A SMALL BROWN PIECE OF PAPER/CARDBOARD. THE OBJECT APPEARED TO BE LOOSE, LOOKED LIKE A STRAY PIECE OF CARDBOARD. THE CABLE WAS NOT USED. THE EVENT WAS ASSESSED AS MDR REPORTABLE FOR FOREIGN MATERIAL INSIDE THE PACKAGING OUTSIDE OF SPECIFICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17056900 ↗

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