Recall of Carbomedics

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Carbomedics, 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
  • 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
    Holder, Heart-Valve, Prosthesis - Product Code DTJ
  • Reason
    Excessive cleaning and resterilization cause cracking and crazing of device causing the device to malfunction during use.
  • Action
    Letters were sent to surgeons and hospital operating room supervisors in mid-May 2002 which included the following information: It is imperative that hospitals regularly and thoroughly inspect all testing instruments for indications of wear and degredation. And, CarboMedics is in the process of re-issuing suggested maintenance and sterilization guidlines.


  • Model / Serial
    All lots
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    US nationwide and to the following foreign countries: Denmark, Ireland, China, Cyprus, Greece, France, UK, Protugal, Ecuador, India, Japan, Hong Kong, Italy, Sweden, Belgium, Norway, Argentina, Spain, Malta, Austria, Switzerland, Netherlands, Germany, Australia, Finland
  • Product Description
    Carbomedics VT-200 Valve Tester
  • Manufacturer


  • Manufacturer Address
    Carbomedics, Inc, 1300 E Anderson Ln, Austin TX 78752-1708
  • Source