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
    25635
  • Event Risk Class
    Class 2
  • Event Number
    Z-0673-03
  • Event Initiated Date
    2003-02-18
  • Event Date Posted
    2003-03-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-07-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26186
  • 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 donor tissue.
  • Action
    Medical facilities were contacted by CryoLife Technical Representatives via letter on/about 2/20/2003 to alert the facility of the removal and to determine the disposition of the allografts. Firms were advised, if the tissue has not been implanted, not to implant or distribute the tissue and to place it into quarantine. Consignees were to contact CryoLife''s Regulatory Affairs Department-Field Assurance, and a representative would issue a Return Materials Authorization number and will provide specific instructions for returning the tissue. There is a stamped, self addressed postcard attached to affirm receipt of the notification.

Device

Device Recall CryoValve Allograft
  • Model / Serial
    Donor #61266, Serial # 7701969, Model #AV00; Donor #63307, Serial #7899279, Model # SGAV00; Donor #64489, Serial #7869356, Model # SGPV00; Donor #65674, Serial # 7957300 Model #SGPV00; Donor #64879, Serial # 7883273, Model #SGPV00; Donor #64697, Serial #7876274, Model #PV00.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Tissue products were distributed to Medical facilities located in CA, MD, ME and SD. There were no foreign or 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