Events

Recall of PentaRay Nav Catheter (used for multiple electrode electrophysiological mapping of cardiac structures in 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-2014-RN-00519-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-05-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00519-1
  • 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
    Biosense webster, a division of johnson and johnson medical, has identified an issue in the production process of the pentaray nav catheter that can lead to an insufficient bond of the distal tip to the catheter shaft. to date, with regard to the affected products, biosense webster has not received any reports of: (i) a complete tip separation from the shaft; or (ii) patient injuries or adverse events as a result of a partial tip separation from the shaft. there is no concern for patients who have already been successfully mapped with the affected products. the incidence rate of the tip to shaft separation is 0.11 % . partial separation exposes the internal components of the catheter to intracardiac blood and could lead to thrombus formation and could become a potential embolic source.
  • Action
    Customers are advised to immediately check their inventory to quarantine if there are affected products.

Device

PentaRay Nav Catheter (used for multiple electrode electrophysiological mapping of cardiac struct...
  • Model / Serial
    PentaRay Nav Catheter (used for multiple electrode electrophysiological mapping of cardiac structures in the heart)Product codes: D128201, D128202, D128204, & D128205All lot numbersARTG number: 203362
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd