Events

Recall of Device Recall Cryovalve(R) SG Pulmonary Human Heart Valve

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
    80199
  • Event Risk Class
    Class 2
  • Event Number
    Z-2271-2018
  • Event Initiated Date
    2018-05-14
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164840
  • 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 OHA
  • Reason
    Devices, which met fda and aatb eligibility criteria, were distributed. final autopsy and toxicology reports indicated the presence of morphine in the urine.
  • Action
    The firm notified the consignees by letter on 05/14/2018.

Device

Device Recall Cryovalve(R) SG Pulmonary Human Heart Valve
  • Model / Serial
    Serial Number 10988203
  • Product Classification
    Cardiovascular Devices
  • Device Class
    Unclassified
  • Implanted device?
    Yes
  • Distribution
    AR, OH
  • Product Description
    Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO
  • 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