Events

Recall of GUIDELINER Intravascular Guiding Catheter

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Pyramed 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-2012-RN-00779-3
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-08-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00779-3
  • 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
    Guideliner catheter is being recalled due to a regulatory compliance issue. guideliner catheter has now been cancelled from the australian register of therapeutic goods (artg) because it should have been classified as a class iii medical device, not a class iia medical device in accordance with the therapeutic goods (medical devices) regulations 2002. the guideliner catheter has not undergone the more rigorous pre-market conformity assessment procedure relevant to a class iii device to provide assurance of its quality, safety and performance. in particular, the tga has not been provided with appropriate data on the design verification and validation of the device necessary for a class iii classification.
  • Action
    Pyramed is asking customers to identify and quarantine the Guideliner Catheter stock and advising that it cannot be used other than in accordance with the specific conditions attached to the Special Access Scheme (SAS).

Device

GUIDELINER Intravascular Guiding Catheter
  • Model / Serial
    GUIDELINER Intravascular Guiding Catheter Previous ARTG: 180817All remaining stock in the market
  • Manufacturer
    Pyramed Pty Ltd

Manufacturer

Pyramed Pty Ltd