Recall of Device Recall St. Jude Medical CPS Implant Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by St Jude Medical CRMD.

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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, Percutaneous - Product Code DQY
  • Reason
    Sterility-some of the sterile pouches in which these products are packaged may not have been properly sealed during their packaging process.
  • Action
    The attached 'Dear Hospital Administrator' letter was sent out to our US sales representatives via FedEx on June 1, 2006. The sales representatives have been instructed to send back all of the devices in their inventory and to retrieve and return any remaining devices that were placed into hospital inventory. They are also instructed to deliver the attached 'Dear Hospital Administrator' letter to the appropriate person at each hospital where product is to be removed from the hospital shelf.


  • Model / Serial
    All lots with a manufacturing date of May 30, 2006 or earlier
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Hospitals/Medical Centers in AZ, CA, MS, NY, & PA
  • Product Description
    CPS Implant Kit, Model 410190
  • Manufacturer


  • Manufacturer Address
    St Jude Medical CRMD, 15900 Valley View Ct, Sylmar CA 91342-3577
  • Source