Events

Recall of OPTEASE Retrievable Vena Cava Filter

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Johnson & Johnson Medical Pty Ltd.

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
    RC-2013-RN-01088-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-10-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01088-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    A printing error has been identified on one unit of optease retrievable vena cava filter. the orientation arrow for the femoral approach was printed in the incorrect direction. the error resulted in the filter being implanted upside down, requiring an additional percutaneous procedure to retrieve the filter. all lots of the cordis optease retrievable vena cava filter are being removed, since it cannot be absolutely determined that no other similar printing errors occurred.
  • Action
    Customers are requested to quarantine the affected product prior to returning to JJM.

Device

OPTEASE Retrievable Vena Cava Filter

Manufacturer

Johnson & Johnson Medical Pty Ltd