Events

Recall of Device Recall ISMUS CATH Mapping Catheter with Auto ID Technology,

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
    58884
  • Event Risk Class
    Class 2
  • Event Number
    Z-2664-2011
  • Event Initiated Date
    2011-05-23
  • Event Date Posted
    2011-06-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-10-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100470
  • 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
    Catheter, electrode recording, or probe, electrode recording - Product Code DRF
  • Reason
    The recall was initiated because biosense webster, inc. has recently become aware that 20 electrodes catheters with auto id technology are not being recognized when connected to the carto 3 system.
  • Action
    Biosense Webster, Inc. sent a Customer Notification Letter, dated May 24, 2011, with an Acknowledgement Form and Instructions for Manually Entering the Catheter Identification in the CARTO 3 System to all US and Outside US (OUS) customers who purchased these products. For customers in the US, two letters and forms will be sent via express mail, addressed to the EP/Cardiology Lab and Risk Management Office, respectively. Instructions for manual entry of the catheter identification in the CARTO 3 System are being included in the communication to customers. These instructions will allow customers to input the identity of the catheter into the CARTO 3 System and be able to utilize the catheter. Customers were instructed to complete and return the attached Acknowledgement Form in accordance with the instructions listed on the form. Customers were instructed to contact their BWI representative for any questions.

Device

Device Recall ISMUS CATH Mapping Catheter with Auto ID Technology,
  • Model / Serial
    Catalog # D7R20P14CT
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Belgium, Japan, and Singapore
  • Product Description
    ISMUS CATH Mapping Catheter with Auto ID Technology, Part Number D-1171-34-S, Catalog # || D7R20P14CT || The affected catheters are indicated for multiple electrode electrophysiological mapping of cardiac structures of the heart, i.e. recording or stimulation only.
  • 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