Events

Recall of Edwards Lifesciences EMBOLX Glide Protection System

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
    66305
  • Event Risk Class
    Class 1
  • Event Number
    Z-0091-2014
  • Event Initiated Date
    2013-09-16
  • Event Date Posted
    2013-10-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121971
  • 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
    Edwards lifesciences is recalling certain lots of embol-x glide protection system due to deformation of the cannula tip.
  • Action
    The firm, Edwards Lifesciences, sent an "URGENT FIELD SAFETY NOTICE PRODUCT RECALL-ACTION REQUIRED" letter dated September 16, 2013 via Fed-Ex to its consignees/customers. Consignees were asked to review inventory for the cannulae and remove the cannulae from any kits received; quarantine affected material at site and return product to Edwards LIfesciences, Attn: Santosh Bhagat, 12050 Lone Peak Drive, Draper, UT 84020, Attention: RECALL, RGA #; call Edwards Customer Service at 800-424-3278 to obtain RGA# and replacement product (note: the filter is not affected and does not have to be returned with the cannulae); and complete and return the attached acknowledgment form via fax to Edwards Customer Service at 800-422-9329 within three days of receipt of this Field Safety Notice. If you have any questions, please call Edwards Customer Service at 800-424-3278 from the hours 6:00am - 4:30pm PST or contact your Edwards' sales representative concerning the recall.

Device

Edwards Lifesciences EMBOLX Glide Protection System
  • Model / Serial
    Model No: EXGF24D, EXGF24LLD, EXGF24MMD, EXGF24SSD, EXGF24XLD, EXGF24XSD, EXGFXS2D, EXGF24SS2D, EXGF24MM2D, EXGF24LL2D and EXGF24XL2D.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: US (nationwide) and country of: Canada.
  • Product Description
    Edwards Lifesciences EMBOL-X Glide Protection System; Model Numbers: EXGF24D, EXGF24LLD, EXGF24MMD, EXGF24SSD, EXGF24XLD, EXGF24XSD, EXGFXS2D, EXGF24SS2D, EXGF24MM2D, EXGF24LL2D and EXGF24XL2D. || The EMBOL-X access device is indicated for the perfusion of the ascending aorta during short-term (less than or equal to0¿ 6 hours) cardiopulmonary bypass (CPB) surgery where procedures may require the hemostatic introduction and removal of compatible intravascular devices into the vascular system.
  • 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