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
    28345
  • Event Risk Class
    Class 2
  • Event Number
    Z-0548-04
  • Event Initiated Date
    2003-12-10
  • Event Date Posted
    2004-02-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-07-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31625
  • 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
    As part of this ongoing retrospective review, cryolife has identified a donor who does not meet current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids administered.
  • Action
    The consignee was notified by letter on 12/10/2003. CryoLife received confirmation of receipt of the notification from the physician who reported the tissue was implanted on 04/17/1997.

Device

Device Recall CryoValve
  • Model / Serial
    Donor #29640, Serial #6194362, Model #PV00 (Pulmonary Valve)
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    The allograft was shipped to one physician in TX.
  • Product Description
    CryoValve Pulmonary Valve and Conduit
  • Manufacturer
    Cryolife Inc

Manufacturer

Cryolife Inc
  • Manufacturer Address
    Cryolife Inc, 1655 Roberts Blvd Nw, Kennesaw GA 30144-3632
  • Source
    USFDA