Events

Recall of Device Recall LASSO 2515 Variable Circular Mapping 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
    47522
  • Event Risk Class
    Class 2
  • Event Number
    Z-1703-2008
  • Event Initiated Date
    2008-03-25
  • Event Date Posted
    2008-08-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69666
  • 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
    Electrode Recording Mapping Catheter - Product Code DRF
  • Reason
    This recall was initiated after the firm received several complaints reporting issues with deflection. the catheter may become caught in the mitral valve, requiring surgical procedures, valve may be torn while trying to dislodge, unable to retract the catheter through the sheath and require surgical intervention to remove, pulling on catheter to remove may lead to large atrial septal tear, and sep.
  • Action
    A letter entitled, "Urgent Safety Field Notice" dated March 25, 2008, and certification form were sent to all customers and Johnson & Johnson affiliates who purchased the product in the past year as of March 25, 2008, due to the expiration date. For customers in the US, two letters and forms were sent out - one addressed to the EP/Cardiology Lab and a second to the Risk Management Office. If you have questions or have not received a letter contact Customer Service at 1-800-729-9010.

Device

Device Recall LASSO 2515 Variable Circular Mapping Catheter
  • Model / Serial
    All lots
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Worldwide to: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Columbia, Czechia, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary , Iran, Ireland, Isra¿¿l, Italy, Japan, Lithuania, Luxembourg, Mexico, Middle East, Netherlands, Norway, Panama, Poland, Portugal, Russia, Serbia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom
  • Product Description
    Circular Mapping Catheter-Biosense Webster LASSO 2515 Variable Circular Mapping Catheter- The catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e., recording and stimulation only. The device is designed to obtain electrograms in the atrial regions of the heart. || 20 Poles, US Catalog Number D7L202515RT, EU Catalog Number 35T2515R
  • Manufacturer
    Biosense Webster Inc

Manufacturer

Biosense Webster Inc
  • Manufacturer Address
    Biosense Webster Inc, 3333 S Diamond Canyon Rd, Diamond Bar CA 91765-4701
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA