Events

Recall of Device Recall CryoValve Allograft heart valve

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
    25595
  • Event Risk Class
    Class 2
  • Event Number
    Z-0676-03
  • Event Initiated Date
    2003-01-30
  • Event Date Posted
    2003-03-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-07-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26121
  • 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
    An allograft associated with this donor has been linked to an alleged infection.
  • Action
    A CryoLife Technical Representative notified the consignee by telephone on/about 1/23/2003 to determine the disposition of the allograft. The allograft SID 72552025 (V00) was located in storage at the SUNY University Hospital, Syracuse, NY. The CryoLife representative visited this site on 01/30/2003 to remove the allograft from inventory and return the tissue to CryoLife. After arrival at CryoLife on 02/03/2003, discard of the tissue was initiated following standard procedures for human tissue waste destruction.

Device

Device Recall CryoValve Allograft heart valve
  • Model / Serial
    Model number PV00, Serial Number: 7255205, Donor #56190
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    One unit was distributed to one Hospital facility in NY. There are no foreign or government accounts involved.
  • Product Description
    CryoValve Allograft heart valve
  • Manufacturer
    Cryolife Inc

Manufacturer

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