Events

Recall of Device Recall CARTO 3 Systems

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Biosense Webster, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    61197
  • Event Risk Class
    Class 2
  • Event Number
    Z-1230-2012
  • Event Initiated Date
    2012-02-09
  • Event Date Posted
    2012-03-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107549
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Computer, diagnostic, programmable - Product Code DQK
  • Reason
    Some carto 3 systems may get radio frequency interference through certain interconnected cable configurations resulting in jumping or disappearing catheter icon and/or error messages during ablation.
  • Action
    Three Urgent Customer Notification recall communications were initiated 2/9/12 with Biosense forwarding the notification to customers with affected backplane cards (electrophysiology lab managers, a notification for customers with affected back plane cards (risk managers), and a notification for customers with affected backplane cards and smarttouch module along with customer acknowledgement forms. The letters provides the customers with an explanation of the problem identified and steps to take in the event that the issue is observed. If the steps provided do not resolve the issue, customers are to contact their Biosense Webster representative. A Biosense Webster representative will contact customers to schedule an appointment for the replacement of the Backplane card. Customers were instructed to complete and return the attached Acknowledgement Form in accordance with the instructions listed on the form. If customers have questions, they can contact their BWI representative.

Device

Device Recall CARTO 3 Systems
  • Model / Serial
    Catalog # FG-5400-00  Serial numbers: 11996, 11998, 11999, 12002, 12026, 12031, 12040, 12046, 12047, 12051, 12052, 12057, 12061, 12062, 12063, 12065, 12066, 12067, 12069, 12070, 12075, 12077, 12078, 12086, 12087, 12088, 12089, 12094, 12096, 12098, 12099, and 12111.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, Japan, China, Ireland, Germany, Italy, Slovenia, Indonesia, Poland, Spain, United Kingdom, Switzerland, Belgium, and Canada.
  • Product Description
    CARTO 3 Systems, Product Code M-4800-01 || The intended use of the CARTO 3 System is catheter-based cardiac electrophysiological (EP) procedures.
  • Manufacturer
    Biosense Webster, Inc.

Manufacturer

Biosense Webster, Inc.
  • Manufacturer Address
    Biosense Webster, Inc., 15715 Arrow Hwy, Irwindale CA 91706-2006
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA