Events

Recall of Device Recall Edwards Lifesciences IntraClude IntraAortic Occlusion Device

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
    79650
  • Event Risk Class
    Class 2
  • Event Number
    Z-1929-2018
  • Event Initiated Date
    2018-03-30
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162896
  • 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
    Clamp, vascular - Product Code DXC
  • Reason
    Possible leak at distal open end of the strain relief, which causes medical staff to continue adding inflation fluid to maintain balloon pressure for adequate occlusion of the ascending aorta.
  • Action
    Customers were notified on about 03/30/2018 via an Urgent Medical Device Safety Notice. Instructions included to review the field safety notice and understand the potential hazard, review the recall with appropriate clinical staff at their institution, complete and return the acknowledgement form, and distribute the notification within the organization where potentially affected devices may have been transferred. Questions can be directed to Edwards Customer Service, Monday through Friday at 800-424-3278 form 8:00 AM - 4:00 PM Pacific Time.

Device

Device Recall Edwards Lifesciences IntraClude IntraAortic Occlusion Device
  • Model / Serial
    Lot No. 60876468, 60850885, 6060850886, 60850888, 60850889, 60850890, 60887217, 60887218, 60887219, 60887220, 60930494, 60934623, 60934624, 60934625, 60972889, 60972890, 60972892, 61014406, 61014408, 61014410, 61014411, 61050171, 61050172, 61078031, 61078032, 61097633, 61139239, 61139240, 61139241, 61139242, 61184964, 61184965, 67784966, 61184967, 61204586, 61204587, 61259626, 61259627, 61259628, and 61259629.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, to the states of AL, AZ, CA, CO, CT, FL, GA, IL, IN, KY, MA, MI, MS, MO, NV, NJ, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, and WV; and, the countries of to Australia, Austria, Belgium, Canada, Colombia, Czech Republic, France, Germany, Israel, Italy, Luxembourg, Netherlands, Poland, Romania, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom.
  • Product Description
    Edwards Lifesciences' IntraClude Intra-Aortic Occlusion Device. Packaged in a sterile barrier system. Model Number: ICF100. || Designed to occlude the ascending aorta.
  • Manufacturer
    Edwards Lifesciences, LLC

Manufacturer

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