Events

Recall of Device Recall CryoValve Allograft

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
    25675
  • Event Risk Class
    Class 2
  • Event Number
    Z-0672-03
  • Event Initiated Date
    2003-02-04
  • 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=26246
  • 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
    Microorganisms were detected in distributed allografts.
  • Action
    CryoLife Technical Representatives were notified by telephone on 02/04/2003 and 02/24/2003. Representatives subsequently notified their accounts via letter on/about 02/25/2003 informing the consignees of the removal and advised them not to implant the tissue if it has not been implanted and to place into quarantine. Consignees were to contact CryoLife''s Regulatory Affairs Department ¿ Field Assurance, who will issue a Return Materials Authorization (RMA) number and will provide specific instructions for returning the tissue. A self addressed, stamped postcard was included to provide a response regarding the disposition of the tissue. Health Canada was notified of all voluntary actions on the allografts distributed in Canada.

Device

Device Recall CryoValve Allograft
  • Model / Serial
    Donor #60084, Serial #7769926, Model #PV00 and Donor #55139, Serial #7165235, Model #SGPV00.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    The allografts were distributed to hospitals located in OK and British Columbia, Canada. There were no government accounts.
  • 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