Events

Recall of Vigilance II 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
    52807
  • Event Risk Class
    Class 2
  • Event Number
    Z-0942-2012
  • Event Initiated Date
    2008-09-12
  • Event Date Posted
    2012-02-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84048
  • 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
    Computer, diagnostic, pre-programmed, single-function - Product Code DXG
  • Reason
    Edwards lifesciences has made the decision to initiate a field corrective action for the edwards vigilance ii model: software: versions 00.51, 00.60, 00.61, 00.62, 00.63, 00.64, 00.67, 00.69, 00.71, 00.73 due to the potential of inaccurate injectate cardiac output (ico) measurements.
  • Action
    Edwards initiated two Urgent Product Notification - Action Required letters to all affected customers. The letters identified the affected product, problem, and actions to be taken. The letters instructed users to immediately discontinue use of in-line temperature probes for Intermittent Cardiac Output (ICO) measurements on the Vigilance II instrument and recommends use of the bath probe only (model 9850A) to measure the temperature of the injectate solution for ICO calculations, until software update have been completed. Customers were instructed to complete and return a software upgrade form to Edwards as record of completion. For questions call Edwards Technical Support department at 800-822-9837.

Device

Vigilance II Monitor
  • Model / Serial
    Software: versions 00.51, 00.60, 00.61, 00.62, 00.63, 00.64, 00.67, 00.69, 00.71, 00.73.  Serial numbers: VG000031 to VG007468
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - Nationwide Distribution (USA) - and the countries of: Argentina, Australia/ New Zealand, Brazil, Canada, China, Columbia, Ecuador, Europe, Indonesia, Japan, Korea, Macao, Malaysia, Mexico, Middle East, Peru, Puerto Rico, Singapore, Thailand, Taiwan and Venezuela
  • Product Description
    Vigilance II Monitor Model: VIG2/VIG2E Software: versions 00.51, 00.60, 00.61, 00.62, 00.63, 00.64, 00.67, 00.69, || 00.71, 00.73. || Product Usage: || The Vigilance II CCO/SvO2/CEDV Monitor is indicated for use in patients requiring monitoring of hemodynamic parameters, including cardiac output, oximetry and right ventricular, ejection, fraction, and end diastolic volume.
  • Manufacturer
    Edwards Lifesciences, Llc

Manufacturer

Edwards Lifesciences, Llc
  • Manufacturer Address
    Edwards Lifesciences, Llc, 1 Edwards Way, Irvine CA 92614-5688
  • Source
    USFDA