Events

Recall of Codman Certas Programmable Valves (Hydrocephalic valve) In Line Valve only with SIPHONGUARD Device, In Line Valve with SIPHONGUARD, Unitized Catheter and Accessories

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-00816-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-07-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00816-1
  • 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 virtual off setting (setting 8) is intended to limit flow through the valve and has an average pressure greater than 400mm h2o. recent in-vitro testing of the virtual off setting showed that the operating pressure for an individual valve may fall below 400mm h2o. this testing found only one occurrence out of 72 test instances that was significantly below 400mm h2o (observed at 275mm h20), although when retested, this valve performed above 400mm h2o. if a valve is considered to be virtually off, but is still operating at a physiologically relevant pressure, a clinician may inaccurately consider the patient to be shunt independent. this may result in a delay in treatment for shunt-related complications. if the virtual off setting is being used to restore ventricular volume for patients with slit ventricle syndrome or subdural haemorrhage formation resulting from overdrainage, treatment response may be delayed for valves operating significantly below 400mm h2o.
  • Action
    Surgeons are advised that: · no action is required if patient is experiencing good outcomes with an implanted valve · be aware that symptoms resulting from this issue would be similar to those seen in the standard course of treatment, so it can be difficult to directly correlate complaints with this problem · If the Virtual Off setting is being used to address an acute overdrainage situation that has resulted in subdural haemorrhage or slit ventricle formation, close observation is advised to make sure that the patient is responding as expected (operating pressure 400mm H2O). Please note that the manufacturer, Codman Neuro is not recommending explanation of CODMAN CERTAS Valves. For more details, please see http://www.tga.gov.au/safety/alerts-device-codman-certas-valves-140729.htm This action has been closed-out on 06/06/2016.

Device

Codman Certas Programmable Valves (Hydrocephalic valve) In Line Valve only with SIPHONGUARD Devic...
  • Model / Serial
    Codman Certas Programmable Valves (Hydrocephalic valve)In Line Valve only with SIPHONGUARD DeviceProduct Code: 82-8804In Line Valve with SIPHONGUARD, Unitized Catheter and AccessoriesProduct Code: 82-8806All lot numbersARTG Numbers: 186235 and 190248
  • Product Classification
    Neurological Devices
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd T/A Depuy Australia

Manufacturer

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia