Events

Recall of Device Recall OnX Ascending Aortic Prosthesis with the Vascutek Gelweave Valsalva Graft

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
    77728
  • Event Risk Class
    Class 2
  • Event Number
    Z-3108-2017
  • Event Initiated Date
    2014-02-12
  • Event Status
    Completed
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157776
  • 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
    Aortic valve, prosthesis, percutaneously delivered - Product Code NPT
  • Reason
    Mix-up rga (return goods authorization) leading to 5 devices being redistributed and implanted 2 patients.
  • Action
    On February 12, 2014, it was discovered that five devices were processed under the wrong RGA number This is a retrospective reporting. Three units were collected and returned to the firm, while two were implanted. For further questions, please call ( 770) 419-3355.

Device

Device Recall OnX Ascending Aortic Prosthesis with the Vascutek Gelweave Valsalva Graft
  • Model / Serial
    Model No. ONXAAP; Serial No. 3260716, 3718302, 3190113, 3194122 and 3634902
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    US Distribution to the state of : Illinois
  • Product Description
    On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use. || Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position in cases that involve an ascending aortic aneurysm or other associated aortic disease.
  • 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