Events

Recall of Atrium Thoracic Catheters, Sizes 8Fr & 10Fr

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-2017-RN-00217-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-02-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00217-1
  • 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
    Current labelling on two models of atrium thoracic catheters requires clarification. for product code numbers 8008 (8fr thoracic catheter) and 8010 (10fr thoracic catheter), the graphical icon depicts a catheter having six (6) eyelets; however the correct number of eyelets on the 8 fr and 10 fr thoracic catheters is two (2).To date, atrium has not received complaints as a result of selecting thoracic catheters that had fewer eyelets than displayed on the product label. although the use of a thoracic catheter with two eyelets may be effective in most patients, the potential risks related to use of the thoracic catheter with two eyelets are: incomplete drainage of pleural effusion or pneumothorax and/or the need for repeated chest tube or pleural drain insertion and/or surgical site infection.
  • Action
    The labelling will be updated for future production. In the interim, customers may continue to use the affected thoracic catheters with the current labelling, and are advised that correct number of eyelets on the 8 Fr and 10 Fr thoracic catheters is two (2).

Device

Atrium Thoracic Catheters, Sizes 8Fr & 10Fr
  • Model / Serial
    Atrium Thoracic Catheters, Sizes 8Fr & 10FrProduct Code Numbers: 8008, 8010All Lot NumbersARTG Number: 97358
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

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