Carto 3 D134401Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10846835009712), received between Mar 2, 2019 and May 16, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K113213); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 16, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT AN UNKNOWN PATIENT WAS TO UNDERGO AN UNKNOWN ABLATION PROCEDURE WITH A CARTO® 3 SYSTEM ECO INTERFACE CABLE. THERE WAS DIRT ON THE UNUSED CABLE WHEN THE PACKAGE WAS OPENED. WHEN THE CUSTOMER OPENED THE POUCH, DIRT WAS ATTACHED ON THE UNUSED CABLE. THE ISSUE WAS RESOLVED BY CHANGING THE CABLE TO ANOTHER ONE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE. NO PATIENT CONSEQUENCES WERE REPORTED. THE BWI COMPANY REPRESENTATIVE CONFIRMED THAT WHEN THE CUSTOMER OPENED THE POUCH, DIRT WAS ATTACHED ON THE UNUSED CABLE. DEVICE RETURNED. FOREIGN MATERIAL INSIDE THE PACKAGING IS MDR-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14404361 ↗
• MalfunctionMar 2, 2019Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE CARTO® 3 SYSTEM ECO INTERFACE CABLE STERILE PACKAGING WAS COMPROMISED AS THERE WAS FOREIGN MATERIAL INSIDE THE PACKAGING OUTSIDE OF SPECIFICATION. INSIDE THE PACKAGING OF THE CARTO® 3 SYSTEM ECO INTERFACE CABLE, THERE WAS A YELLOW MARKING. IT WAS DESCRIBED AS A YELLOW STICKY SUBSTANCE OR ADHESIVE INSIDE THE PACKAGE WITH THE CABLE THAT COMPROMISED THE STERILE PACKAGING. ADDITIONAL INFORMATION WAS RECEIVED ON THE EVENT ON FEBRUARY 11, 2019. THE CARTO® 3 SYSTEM ECO INTERFACE CABLE WAS NEVER USED ON THE PATIENT OR USED IN A LIVE PROCEDURE. THE ISSUES OF THE FOREIGN MATERIAL INSIDE THE PACKAGING WHICH WAS OUTSIDE OF SPECIFICATION WHICH COMPROMISED THE STERILE PACKAGING, WERE ASSESSED AS REPORTABLE.. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. DURING THE VISUAL INSPECTION ON FEBRUARY 25, 2019, IT WAS NOTED THAT THERE WAS NO YELLOW SUBSTANCE FOUND INSIDE OF THE PACKAGING. HOWEVER, THERE WAS YELLOW MATERIAL FOUND ON THE CABLE. THE YELLOW MATERIAL FOUND ON THE CABLE REMAINS A REPORTABLE ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8384694 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113213. One submission often covers many models, so check the product and lot details in each record.

• Z-1617-2013 · Jun 19, 2013 · Terminated
  20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S. Designed to facilitate electrophysiological mapping of the atria of the heart.