Events

Recall of THERMOCOOL SMARTTOUCH NAVIGATION Catheter

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
    69532
  • Event Risk Class
    Class 2
  • Event Number
    Z-0139-2015
  • Event Initiated Date
    2014-10-19
  • Event Date Posted
    2014-10-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-10-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130879
  • 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
    Cardiac ablation percutaneous catheter - Product Code LPB
  • Reason
    The recall was initiated because biosense webster is providing additional labeling for the safe and effective use of the thermocool smarttouch catheter.
  • Action
    A customer notification letter dated October 19, 2014, will be sent to all customers who purchased the Biosense Webster's ThermoCool SmartTouch Catheter Family. The letter informs the customers of the additional information for the safe and effective use of the ThermoCool SmartTouch Catheter, which will be included in the updated labeling. The letter informs the customers of the problems identified and the actions to be taken. Customers with questions related to the recall letter are instructed to contact their Biosense Webster sales representative or call (866) 473-7823, Monday through Friday from 7am to 8pm EST.

Device

THERMOCOOL SMARTTOUCH NAVIGATION Catheter
  • Model / Serial
    Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603  All Lots manufactured from launch (Dec 2010)
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603.
  • 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