Recall of Device Recall Epic II HF Model V355

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
  • Reason
    A condition that could lead to a ventricular sensing anomaly in epic and atlas family of lmplantable cardioverter defibrillators (icds) has been identified. a loss of ventricular sensing would prevent the icd from being able to detect an arrhythmia. if an arrhythmia occurred and the device was unable to detect it, then a patient would not receive potentially life saving therapy.
  • Action
    A January 16, 2008, letter entitled, "Important Device Upgrade Information" was sent to physicians by FedEx. In the US, sales representatives will follow-up with the physician and will upgrade all programmers. For the rest of the world, it will be monitored by various St. Jude offices and local distributors with this information being fed back to St. Jude Medical CRMD in Sylmar. In addition, St. Jude Medical issued a press release on January 18, 2008 and information concerning this advisory can be found on St. Jude's website,


  • Model / Serial
    all serial numbers
  • Distribution
    Nationwide and Internationally: Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Hong Kong, Hungary, India, Italy, Japan, Korea, Malaysia,Mexico, Netherlands, New Zealand, Norway, Peru. Poland, Portugal, Republic of Panama, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad, United Kingdom, Uruguay and Venezuela.
  • Product Description
    Implantable Cardioverter Defibrillator || EPIC II HF Tiered-therapy cardioverter/defibrillator with Biventricular Stimlation, Model V-355
  • Manufacturer


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