Events

Recall of OPTEASE RETRIEVABLE VENA CAVA FILTER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON 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
    107618
  • Event Risk Class
    I
  • Event Initiated Date
    2013-10-08
  • 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
    Cordis has identified a printing error on one unit of optease vena cava filter in which 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 unexpired distributed lots of the cordis optease vena cava filter are being removed since it cannot be absolutely determined that no other similar printing errors occurred. this recall is separate from the correction letter of april 3 2013 (recall number 83564).

Device

OPTEASE RETRIEVABLE VENA CAVA FILTER

Manufacturer

JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.