Events

Recall of Penumbra System Aspiration Pump - Pump Max, PMX220Multiple Lot Numbers

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Penumbra Neuro 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-2018-RN-00228-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2018-03-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00228-1
  • 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 australian sponsor address was inadvertently omitted from the pump max labelling.To date, no user complaints have been received regarding this issue.
  • Action
    Penumbra is providing users with a label containing the Australian Sponsor details to affix to devices. Users should refer to the images provided on the Customer Letter for correct location as to where labels should be placed.

Device

Penumbra System Aspiration Pump - Pump Max, PMX220Multiple Lot Numbers
  • Model / Serial
    Penumbra System Aspiration Pump - Pump Max, PMX220Multiple Lot NumbersARTG Number: 213819(Penumbra Neuro Australia - Suction unit, electric powered)
  • Manufacturer
    Penumbra Neuro Australia Pty Ltd

Manufacturer

Penumbra Neuro Australia Pty Ltd