Recall of Defibrillator PCA wihtin the monitor of the LifeVest

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zoll Lifecor Corporation.

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
    wearable, defibrillator, automatic, external - Product Code MVK
  • Reason
    The charging circuit will not shut down properly.
  • Action
    Physicians with active patients were notified of the product removal by letter via first-class mail dated 10/21/2008. The letter describes the problem and the potential risk. For additional information, contact ZOLL Lifecor Corporation at 1.800.543.3267.


  • Model / Serial
    model numbers WCD3000 and WCD3100
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Nationwide. OUS: Germany, United Kingdom, Italy, and France.
  • Product Description
    Monitor portion of the LifeVest device - specifically the Defibrillator printed circuit assembly (PCA) within the monitor. || The LifeVest is indicated for adult patients who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator.
  • Manufacturer


  • Manufacturer Address
    Zoll Lifecor Corporation, 121 Freeport Rd, Pittsburgh PA 15238-3411
  • Source