Events

Recall of HLS Cannulae (Used for the cannulation of suitable vessels during extra corporeal circulation as inflow or outflow cannula)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Maquet Australia 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-01015-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-10-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01015-1
  • 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
    In some very rare cases, it was not possible to insert the guide wire through the introducer of the hls-cannulae. the investigation identified that the hole in the grip of the introducer was partly blocked and the guide wire could not be pushed through. the problem occurs prior to vascular access and the cannulae itself functions properly during perfusion.
  • Action
    Quarantine and return affected devices to MAQUET

Device

HLS Cannulae (Used for the cannulation of suitable vessels during extra corporeal circulation as ...
  • Model / Serial
    HLS Cannulae (Used for the cannulation of suitable vessels during extra corporeal circulation as inflow or outflow cannula)Multiple catalogue and lot numbersARTG Numbers: 188929 and 189286
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

Maquet Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    DHTGA