Events

Recall of Aortic Perfusion 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
    35291
  • Event Risk Class
    Class 2
  • Event Number
    Z-1089-06
  • Event Initiated Date
    2006-04-18
  • Event Date Posted
    2006-06-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-06-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45730
  • 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
    Due to potential embrittlement of the plastic tip which may crack or separate during use.
  • Action
    Consignees were notified by letter and visit beginning 04/18/2006.

Device

Aortic Perfusion Cannula
  • Model / Serial
    REF: A3221190A. Lot Number 58194673
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA, CT, FL, IN, KS, MA, MI, TN, TX. No Military or government consignees. Foreign distribution to Australia, Chile, EU, India, Singapore, Taiwan
  • Product Description
    Aortic Perfusion Cannula with plastic tip, 22 Fr. x 28 cm || Edwards Lifesciences
  • Manufacturer
    Edwards Lifesciences Research Medical, Inc.

Manufacturer

Edwards Lifesciences Research Medical, Inc.
  • Manufacturer Address
    Edwards Lifesciences Research Medical, Inc., 6864 Cottonwood St, Midvale UT 84047-1083
  • Source
    USFDA