Events

Recall of Device Recall 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
    25832
  • Event Risk Class
    Class 2
  • Event Number
    Z-0723-03
  • Event Initiated Date
    2003-03-19
  • Event Date Posted
    2003-04-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-05-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26557
  • 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
    unknown device name - Product Code LMO
  • Reason
    The recipient of one of the kidneys from the donor has developed renal cell carcinoma.
  • Action
    Implanting physicians were notified by letter on 3/19/2003. Since CryoLife has been notified that the allografts have been implanted, the notification is intended to provide the physician with a basis to determine if any additional patient surveillance or intervention is necessary. They were advised to complete an enclosed, stamped, self-addressed postcard to affirm receipt of the notification.

Device

Device Recall CryoValve
  • Model / Serial
    Aortic Valve & Conduit, Donor #34695, Serial #6356206, Model #AV00 and Pulmonary Valve & Conduit, Donor #34695, Serial #6356214, Model #PV00.
  • Distribution
    Allografts were distributed to 2 physicians in NY and MS. Allografts were implanted.
  • Product Description
    CryoValve Heart-valve, allograft
  • Manufacturer
    Cryolife Inc

Manufacturer

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