Carto 3 CY1212CTRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10846835003925), received between May 26, 2022 and May 26, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (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 18, 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 26, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A CARTO® 3 SYSTEM INTERFACE CABLE. THE PACKAGE WAS OPEN AND NOT SEALED. IT WAS REPORTED THAT WHEN THEY WENT TO OPEN THE NEW SYSTEM INTERFACE CABLE, THE PACKAGING WAS NOT SEALED. THE CABLE WAS REPLACED, AND THE PROCEDURE CONTINUED. NO PICTURE OF THE PACKAGING IS AVAILABLE. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. THE OPEN POUCH SEAL ISSUE WAS ASSESSED AS A MDR REPORTABLE PRODUCT MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14519305 ↗

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