Events

Recall of Device Recall VIGILANCE MONITOR

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
    35777
  • Event Risk Class
    Class 2
  • Event Number
    Z-1310-06
  • Event Initiated Date
    2006-06-21
  • Event Date Posted
    2006-08-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-08-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46857
  • 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 output monitor - Product Code DYG
  • Reason
    Edwards lifesciences vigilance monitors with software release 5.3 or earlier may improperly cause the monitor to deliver power to the continuous cardiac output (cco) catheter without alerting the user to this situation. this can result in overheating and thermal damage to the cco catheter and serious patient injury.
  • Action
    Strategy to contact affected physicians accounts: Edwards will communicate to all accounts with affected monitors using distribution and sales records to identify those accounts. Letter dated 07/07/2006. In addition Edwards will analyze all CCO catheter sales and identify all accounts not on the monitor distribution list and include those accounts on the communication listing. Communication will be send via FedEx to the Risk Manager at each account with sufficient copies for the Heads of Departments of Surgery, Anesthesia, ICU, Nursing, Risk Management and Biomedical Engineering. Edwards will follow up by phone with each account that does not initiate contact per the Recall Letter. Edwards will make three attempts to contact the account by phone and complete the recall process.

Device

Device Recall VIGILANCE MONITOR
  • Model / Serial
    Lot Numbers: All devices serialized with software release 5.3 or earlier.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide
  • Product Description
    EDWARDS VIGILANCE MONITORS || (FORMERLY BAXTER VIGILANCE MONITORS) || with software release 5.3 or earlier only. Patient monitor which measures cardiac output. || Models: VG, VGS, VGS1, VGS2, VG2, & IVM.
  • Manufacturer
    Edwards Lifesciences Llc

Manufacturer

Edwards Lifesciences Llc
  • Manufacturer Address
    Edwards Lifesciences Llc, One Edwards Way, Irvine CA 92614-5688
  • Source
    USFDA