Events

Recall of Cordis EMPIRA NC RX PTCA Dilatation Catheter (“75RxxyyyN”) and Cordis EMPIRA RX PTCA Dilatation Catheter (“85RxxyyyS”)(indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion)

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-2014-RN-00715-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-07-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00715-1
  • 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
    Through the investigation of the complaints, cordis and creganna-tactx have observed that the balloon of the affected product, which is covered with a hydrophilic coating, may exhibit resistance to the removal of the balloon cover. weakening of the affected product in the region of the proximal balloon seal may occur when excessive force is applied to remove the balloon cover. use of a weakened catheter may lead to balloon burst, shaft separation or deflation difficulties, which could result in procedural delay, vessel trauma or surgery. there is no concern for patients who have already been treated successfully with the affected product.
  • Action
    Johnson & Johnson Medical is advising end users that if unusual force is required during the removal of the shipping stylet and/or balloon cover, the unit is not be used. This warning is also being added to the product labelling.

Device

Cordis EMPIRA NC RX PTCA Dilatation Catheter (“75RxxyyyN”) and Cordis EMPIRA RX PTCA Dilatation C...
  • Model / Serial
    Cordis EMPIRA NC RX PTCA Dilatation Catheter (“75RxxyyyN”) and Cordis EMPIRA RX PTCA Dilatation Catheter (“85RxxyyyS”)(indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion)All Catalog Numbers and all unexpired Lots
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd