Events

Recall of Device Recall SynerGraft 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
    57730
  • Event Risk Class
    Class 2
  • Event Number
    Z-1219-2011
  • Event Initiated Date
    2011-01-07
  • Event Date Posted
    2011-02-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-11-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97128
  • 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
    A pre-processing culture performed on a companion allograft (aortic valve & conduct sg) tested positive for staphylococcus aureus.
  • Action
    The firm, Cryolife, sent an "Urgent-Human Tissue Recall" letter dated January 7, 2011 to the consignee/customer. The letter describe the product, problem and action to be taken by the customer. The customer was instructed to determine if any additional patient surveillance or intervention was necessary, and to complete and return the enclosed postcard affirming that the notification was received. If you have any questions, please contact Cryolife's Medical Director at 1-678-290-4403.

Device

Device Recall SynerGraft CryoValve
  • Model / Serial
    Serial Number 9748180
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide distribution: USA state of: MI
  • Product Description
    Pulmonary Valve & Conduit SG || Used in heart surgery
  • Manufacturer
    CryoLife, Inc.

Manufacturer

CryoLife, Inc.
  • Manufacturer Address
    CryoLife, Inc., 1655 Roberts Blvd Nw, Kennesaw GA 30144-3632
  • Manufacturer Parent Company (2017)
    Cryolife Inc.
  • Source
    USFDA