Events

Recall of Device Recall CryoValve Pulmonary Valve & Conduct

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cryolife 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
    27664
  • Event Risk Class
    Class 2
  • Event Number
    Z-0167-04
  • Event Initiated Date
    2003-11-04
  • Event Date Posted
    2003-11-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-05-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30303
  • 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
    Heart-Valve, Allograft - Product Code MIE
  • Reason
    Cryolife received information that an allograft associated with the donor had been linked to a complaint of an alleged positive pre-implant culture. specifically clostridium baratii was detected on the pre-implant culture performed at the implanting hospital site.
  • Action
    Consignee was notified by letter on 11/4/2003. The tissue was reported implanted on 10/14/2003. The letter was intended to provide the hospital with a basis to determine if any additional patient surveillance or intervention is necessary. A self addressed, stamped postcard was enclosed to verify receipt of notification.

Device

Device Recall CryoValve Pulmonary Valve & Conduct
  • Model / Serial
    Model Number PV00, Serial Number 8041312
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    The tissue was shipped to one hospital in MO.
  • Product Description
    CryoValve Pulmonary Valve & Conduct
  • Manufacturer
    Cryolife Inc

Manufacturer

Cryolife Inc
  • Manufacturer Address
    Cryolife Inc, 1655 Roberts Blvd Nw, Kennesaw GA 30144-3632
  • Source
    USFDA