Events

Recall of Carto 3 EP Navigation System

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
    72167
  • Event Risk Class
    Class 2
  • Event Number
    Z-0002-2016
  • Event Initiated Date
    2015-09-10
  • Event Date Posted
    2015-10-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140077
  • 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
    Image disappeared from the cardiac ultrasound system when the carto 3 ep navigation system needed restarting while the patient was experiencing pericardial effusion. affects the cartosound module of the carto 3 ep navigation system when used with the soundstar eco 8f and 10f diagnostic ultrasound catheters. new precautions added.
  • Action
    A Customer Notification Letter and Acknowledgement Form was distributed to customers on 09/10/15. One letter and form was sent via express mail, addressed to the Risk Management Office and one additional letter and form was sent by the firm's account representative to the Electrophysiology (EP/Cardiology Lab directly at the customer site. The firm's notification letter stated that they want to emphasize the following statement "The intra-cardiac ultrasound image will disappear if the CARTO 3 EP Navigation System power is disrupted and this may present a safety issue if the EP is using the ultrasound to monitor the patien during EP procedure. The ultrasound image will not reappear until the CARTO 3 System is restored." The firm will be updating the product labeling to further reinforce the precautionary statement. The firm requests that customers take the following actions: 1. Read the Field Safety Notification carefully. 2. Pass on this notification to anyone in the facility that needs to be informed of this issue, including appropriate clinical personnel involved in the use of SOUNDSTAR¿ eco Catheters. 3. Review, complete, sign and return the attached Acknowledgement Form in accordance with the instructions on the form. 4. Maintain a copy of this letter with the product. 5. Maintain awareness of the Field Safety Notification For any questions the firm states to contact the BWI sales representative.

Device

Carto 3 EP Navigation System
  • Model / Serial
    Catalog #: C3SOUND, 10439236, 10439072, 10439011, 10438577
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution. US nationwide, Italy, Canada, Japan, China, Singapore, Colombia, England, Russia, Spain, France, Germany, Finland, Ireland, Australia, Sweden, Hungary, India, Brazil, Slovenia, Netherlands, Mexico, and South Africa.
  • Product Description
    Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps.
  • 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