Events

Recall of Device Recall Edwards Lifesciences Duraflo coated FemFlex II Femoral Arterial Cannula

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
    64782
  • Event Risk Class
    Class 2
  • Event Number
    Z-1111-2013
  • Event Initiated Date
    2013-03-14
  • Event Date Posted
    2013-04-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-03-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117064
  • 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, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
  • Reason
    Two unsealed pouches were found at an edwards' distribution location in japan. incorrectly sealed pouches may result in a sterility barrier breach.
  • Action
    Edwards Lifesciences sent an Urgent Field Safety Notice letter dated March 28, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue use of any affected product remaining in inventory and to return any unused devices to Edwards. A completed Acknowledgement Form should be faxed to Edwards at 800-422-9329 within three days of receiving the notice. Questions regarding the recall should be directed to Edwards Customer Services at 800-424-3278, 6:00AM - 4:30PM PST.

Device

Device Recall Edwards Lifesciences Duraflo coated FemFlex II Femoral Arterial Cannula
  • Model / Serial
    Model DIIFEMII018A, Lot 59337174
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA Nationwide Distribution including the states of: FL, MA, MI, NY, PA, TX.
  • Product Description
    Edwards Lifesciences Duraflo coated Femoral Cannula. || Product Usage: || The cannulae are intended for use in situations which require rapid femoral venous and arterial access for short-term (< 6 hours) cardiopulmonary bypass. Vessel access (venous or arterial) is left to the discretion of the physician. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin-coated blood path is desired. || The femoral arterial cannulae are wire-reinforced, thin-wall cannulae.
  • Manufacturer
    Edwards Lifesciences, LLC

Manufacturer

Edwards Lifesciences, LLC
  • Manufacturer Address
    Edwards Lifesciences, LLC, 12050 Lone Peak Pkwy, Draper UT 84020-9414
  • Manufacturer Parent Company (2017)
    Edwards Lifesciences Corporation
  • Source
    USFDA