Events

Recall of CryoValve

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
    26985
  • Event Risk Class
    Class 2
  • Event Number
    Z-1188-03
  • Event Initiated Date
    2003-04-01
  • Event Date Posted
    2003-08-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-10-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28946
  • 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 initiated a retrospective review per fda request, to insure that current regulatory guidelines for donor blood testing have been met for certain donors.
  • Action
    Consignees were notified by letter sent on various dates starting April, 2003 and were advised to provide the disposition of the tissue to CryoLife.

Device

CryoValve
  • Model / Serial
    Donors processed prior to 1/26/1998
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Tissues were distributed to hospitals and physicians located nationwide and worldwide.
  • Product Description
    CryoValve Heart Valve
  • Manufacturer
    Cryolife Inc

Manufacturer

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