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
    27949
  • Event Risk Class
    Class 2
  • Event Number
    Z-0516-04
  • Event Initiated Date
    2003-11-10
  • Event Date Posted
    2004-02-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-05-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30787
  • 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
    The firm received additional information from the procurement agency indicating that yeast was detected in the musculoskeletal procurement cultures for the hemi pelvis.
  • Action
    Consignee was first notified by telephone on 11/10/2003, with a follow up letter sent 12/10/2003. If the tissue had been implanted the consignee was advised to forward that information to CryoLife''s Regulatory Department-Field Assurance. If the tissue had not been implanted the consignee was advised not to implant or further distribute the tissue. They were instructed to remove the tissue from the implantable inventory and to place it into quarantine pending return to CryoLife. A self addressed, stamped postcard was included to affirm receipt of notification and to acknowledge that the tissue had been placed into quarantine.

Device

Device Recall CryoValve
  • Model / Serial
    Donor number: 71237, Serial number: 8214013, Model number: PV00
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    The tissue was issued to one hospital in CA.
  • Product Description
    CryoValve, Pulmonary Valve & Conduit
  • Manufacturer
    Cryolife Inc

Manufacturer

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