Events

Recall of Device Recall Edwards Lifesciences SwanGanz Thermodilution VIP Catheters

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Edwards Lifesciences, LLC.

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
    62278
  • Event Risk Class
    Class 2
  • Event Number
    Z-2189-2012
  • Event Initiated Date
    2012-05-11
  • Event Date Posted
    2012-08-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-06-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110075
  • 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, flow directed - Product Code DYG
  • Reason
    The device is being recalled because the firm received multiple complaints related to passage of a j-tip guidewire when inserted through the distal lumen hub of the catheter.
  • Action
    Edwards Lifesciences sent a "PRODUCT RECALL" letter dated May 8, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Confirmation Form was attached for customers to complete and return via fax to 1-800-422-9329. Contact Customer Service at 1-800-424-3278 for questions regarding this notice.

Device

Device Recall Edwards Lifesciences SwanGanz Thermodilution VIP Catheters
  • Model / Serial
    59194311, 59194312, 59194313, 59197002, 59197003, 59197893, 59197894, 59197895, 59197896, 59203369, 59203370, 59203371, 59203372, 59203373, 59219841, 59219842, 59219844, 59219845, 59224417, 59247409, 59247410, 59247411, 59247413
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Canada, Japan, EMEA (Europe, Middle East and Africa), Asia Pacific, (Hong Kong, Indonesia, Malaysia, Australia, and Taiwan, Thailand), Latin America, (Chile, Colombia, Panama, Mexico, and Honduras).
  • Product Description
    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7P. || For use in patients who require hemodynamic monitoring.
  • Manufacturer
    Edwards Lifesciences, LLC

Manufacturer

Edwards Lifesciences, LLC