Events

Recall of Codman Neuro EDS 3 CSF External Drainage Systems (indicated for draining cerebrospinal fluid (CSF) and other fluids when the insertion of a permanent internal shunt is not indicated)

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

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-01009-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-09-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01009-1
  • 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 tubing within the system that drains csf may leak or disconnect from the joints. leakage and tube separations may result in over- or under-drainage of csf from the ventricular system or introduction of air into the ventricular system (pneumocephalus). this may result in collapsed ventricles, subdural bleeding, or an inability to properly control elevated intracranial pressure. the tubing disconnection or leakage may also increase the risk of ventriculitis. if undetected or untreated each of these events may cause severe brain injury, which may lead to coma, stroke or death. these systems are most often used on neurocritical care floors and these issues are likely to be detected immediately.
  • Action
    Johnson & Johnson Medical Pty Ltd (JJM) is issuing a two stage recall action to mitigate the risk of shortage for these devices in the market place. STAGE 1 - INFORM: Inform customers regarding the product issues and what actions need to be undertaken in the interim. STAGE 2 - RECALL: Customers should return affected product to JJM once they have sourced alternate product. In the case where no substitute drainage system is immediately available, the EDS 3 System may continue to be used until an alternative product can be obtained. Manipulation of tubing should be minimised and extra vigilance (identified in the customer letter) is required for early detection of leakage and/or disconnection. After the alternative products have been sourced by customers, affected products should be quarantined for returning it to JJM. This action has been closed-out on 28/02/2018,

Device

Codman Neuro EDS 3 CSF External Drainage Systems (indicated for draining cerebrospinal fluid (CSF...
  • Model / Serial
    Codman Neuro EDS 3 CSF External Drainage Systems (indicated for draining cerebrospinal fluid (CSF) and other fluids when the insertion of a permanent internal shunt is not indicated)EDS 3CSF External Drainage System with Ventricular CatheterPart number: 82-1730ARTG: 123236EDS 3CSF External Drainage System (no Ventricular Catheter)Part number: 82-1731ARTG:122785Lumbar Drainage Catheter Kit II with EDS 3System Part number: 82-1738All lot numbers affectedARTG: 123489
  • Product Classification
    Neurological Devices
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd T/A Depuy Australia

Manufacturer

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia