Events

Recall of CRYOVALVE PULMONARY VALVE AND CONDUIT ALLOGRAFT

According to Health Canada (via FOI), this recall involved a device in Canada 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
    31553
  • Event Risk Class
    II
  • Event Initiated Date
    2013-05-22
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Cryolife was notified by the tissue bank that recovered this donor tissue of inconsistenceies in the medical/social history interview. specifically one or more questions that were used in determining donor eligibility were either not asked of the donor family or was not appropriately asked.

Device

CRYOVALVE PULMONARY VALVE AND CONDUIT ALLOGRAFT
  • Model / Serial
    Model Catalog: PV00 (Lot serial: 9860382)
  • Product Description
    CRYOVALVE PULMONARY VALVE AND CONDUIT ALLOGRAFT
  • Manufacturer
    CRYOLIFE INC.

Manufacturer

CRYOLIFE INC.
  • Manufacturer Address
    KENNESAW
  • Manufacturer Parent Company (2017)
    Cryolife Inc.
  • Source
    HC