Events

Recall of Device Recall SynerGraft CryoValve Pulmonary Valve and Conduit SG

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
    57974
  • Event Risk Class
    Class 2
  • Event Number
    Z-1560-2011
  • Event Initiated Date
    2011-02-17
  • Event Date Posted
    2011-03-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97897
  • 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, more than minimally manipulated allograft - Product Code DXZ
  • Reason
    Staphylococcus aureus (not methicillin resistant) identified in companion tissue.
  • Action
    CryoLife Inc. issued a letter to the physician on February 17, 2011, advising him of the results of the testing performed on a companion cardiac allograft. The letter did not recommend explant of the allograft or special antimicrobial treatment of the patient unless medically necessary. The physician was asked to complete and return the enclosed, stamped, self-addressed postcard affirming the receipt of the notification. For any questions the physician was advised to call 770-419-3355.

Device

Device Recall SynerGraft CryoValve Pulmonary Valve and Conduit SG
  • Model / Serial
    Serial No. 9560908 - Model SGPV00
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including AZ & NV
  • 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