Events

Recall of Biosense Webster PENTARAY NAV and PENTARAY NAV eco Catheters (used for electrophysiological mapping of the heart)

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-2016-RN-00488-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-04-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00488-1
  • 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
    The manufacturer, biosense webster, is clarifying the contraindication language in the instructions for use (ifu) and product labelling for use of this catheter relative to patients with prosthetic valves. the current language in the ifu provides a precaution against use of the pentaray catheter in patients with prosthetic valves under the contraindication section stating: “[the] use of this catheter may not be appropriate for use in patients with prosthetic valves.” the update to the ifu is to clarify the contraindication statement to the following: “do not use pentaray catheters in patients with prosthetic valves”.If excessive force is applied on the entangled catheter spine, there is a potential for parts to detach and embolise inside the patient’s body, which may lead to serious complications like stroke, transient ischemic attack, myocardial infarction or pulmonary embolism. the likelihood of these serious complications remains low.
  • Action
    Johnson and Johnson Medical (JJM) are providing users with an updated IFU to follow to ensure the products are not used in patients with prosthetic valves. This action has been closed-out on 10/05/2017.

Device

Biosense Webster PENTARAY NAV and PENTARAY NAV eco Catheters (used for electrophysiological mappi...
  • Model / Serial
    Biosense Webster PENTARAY NAV and PENTARAY NAV eco Catheters (used for electrophysiological mapping of the heart)Catalogue Numbers: D128201, D128202, D128203, D128204, D128205, D128206, D128207, D128208, D128209, D128210, D128211, D128212All Lot Numbers affectedARTG numbers: 129479, 203362, 231772
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd