Events

Recall of Device Recall 20Pole LASSO Nav Catheter Eco

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
    65506
  • Event Risk Class
    Class 2
  • Event Number
    Z-1617-2013
  • Event Initiated Date
    2013-06-19
  • Event Date Posted
    2013-06-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-02-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119395
  • 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 - Product Code DRF
  • Reason
    Biosense webster is recalling the 20-pole lasso nav catheter eco because it has been incorrectly calibrated causing them to be recognized and displayed as a 10-pole lasso nav catheter eco by the carto 3 system.
  • Action
    An Urgent Field Notice letter was sent to all their customers who purchased the 20-Pole LASSO NAV Catheter Eco. The letter informed the customers of the problem identified and the actions to be taken. Customers are instructed to complete and return the attached Voluntary Field Removal Certification Form in accordance with the instructions listed on the form. Customers are instructed to contact Biosense Webster sales representatives or call (866) 473-7823, Monday-Friday from 7:00AM to 8:00 PM EST if they have any questions. For questions related to the Voluntary Field Removal Certification Form and its return, customers are instructed to contact the Field Action Coordinator, at (909) 839-8468.

Device

Device Recall 20Pole LASSO Nav Catheter Eco
  • Model / Serial
    Lot # 15832314L
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the states of MN, FL, and UT.
  • Product Description
    20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S. || Designed to facilitate electrophysiological mapping of the atria of the heart.
  • 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