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
    75012
  • Event Risk Class
    Class 2
  • Event Number
    Z-2776-2016
  • Event Initiated Date
    2016-08-15
  • Event Date Posted
    2016-09-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-01-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149112
  • 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
    Biosense webster, inc. is initiating a voluntary correction to re-install identified carto 3 systems that were moved and installed in china without testing and approval by biosense webster technical services, as described in the instructions for use (ifu).
  • Action
    Biosense Webster sent a Customer Notification letter dated August 23, 2016, to all affected customers to inform them that Biosense Webster, Inc. recently became aware that some systems were improperly transported and installed at hospitals in China by Biosense Webster, Inc. Clinical Specialists. The letter informs the customers that according to the CARTO 3 System Instructions for Use (IFU), only the Biosense Webster, Inc. Technical Services team members are authorized to properly install the systems. Customers are informed that each impacted CARTO 3 System must be fully tested and approved by the Biosense Webster, Inc.Technical Services Team. The letter informs the customers of the actions to be taken. Actions Requested on Your Part: 1. Read this Medical Device Correction notification carefully. 2. If a CARTO¿ 3 System currently resides within your hospital, the system has been corrected, and you should ensure that you have received a Field Service Report that indicates the system is in order. For questions regarding this recall call 909-839-8500. 3. Review, complete, sign, and return the Acknowledgement Form in accordance with the instructions listed on the form. 4. In the future, if a CARTO¿ 3 System is installed in your facility, you should only conduct a clinical procedure after you have received a Field Safety Report dated after the installation of the device indicating that the system is in order. 5. Maintain awareness of this notice and pass this notice on to anyone in your facility that needs to be informed. Customers with any questions are instructed to contact their Biosense Webster, Inc. sales representative.

Device

CARTO 3 EP Navigation System
  • Model / Serial
    V 3.2: 2258, 10284, 10332, 10345, 11640, 11642, 60011, 60012, 60606, 60611, 60613, 60618, 60621, 60625, 60634, 60644, 60651, 60654, 60657, 60658, 60660, 60661, 60664, 60671, 60673, 60674, 60680, 60682, 60683, 61000, 61002, 61005, 61010, 61014, 61038, 61039, 61041, 61045, 61046, 61050, 61055, 61060, 61062, 61064, 61071, 61501, 66114, 66115, 66117, 66118, 66119, 29306, 13173, 13213, 11567, 14528  V 4.3: 61053, 61054, 61059, 11701, 12664  V 2.3: 14218, 13208, 50203, 50531, 14718, 50573
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    International Distribution to China, Hong Kong and Brazil.
  • Product Description
    CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and FG540000C, Software Versions: v 3.2 , v 4.3 and v 2.3. || The CARTO 3 EP Navigation System is intended to be used in catheter-based cardiac electrophysiological (EP) procedures. The CARTO 3 System provides information about the electrical activity of the heart and catheter location during the procedure.
  • 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