Events

Recall of Device Recall Aortic cannula

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Edwards Lifesciences Research Medical Inc.

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
    30623
  • Event Risk Class
    Class 2
  • Event Number
    Z-0306-05
  • Event Initiated Date
    2004-11-19
  • Event Date Posted
    2004-12-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-01-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36226
  • 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
    Aortic cannula may delaminate and leak where it is bonded to the tip. this could occur during cardiopulmonary bypass surgery.
  • Action
    All consignees were notified by letter on 11/22/2004

Device

Device Recall Aortic cannula
  • Model / Serial
    Model EX24D, Lot No.: 58174875
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AL, CA, CO, FL, GA, IL, MA, MD, MI, MN, MO, NC, NJ, NM, NV, NY, OR, PA, RI, TN, TX, VA, WA, and WI. No foreign, military or government distribution.
  • Product Description
    EMBOL-X Slim Access Device / Aortic Cannula 24 Fr X 11''.
  • Manufacturer
    Edwards Lifesciences Research Medical Inc

Manufacturer

Edwards Lifesciences Research Medical Inc
  • Manufacturer Address
    Edwards Lifesciences Research Medical Inc, 6864 South 300 West, Midvale UT 84047-1083
  • Source
    USFDA