Events

Recall of Venture RX, OTW and CS Catheters

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-2017-RN-00538-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-04-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00538-1
  • 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 manufacturer vascular solutions (vsi), through an internal investigation has concluded there is the potential for excess material used to manufacture specific venture catheters to be present within the inner lumen of the distal catheter tip. it is possible that the excess material may separate from the catheter during a procedure, posing a potential risk of an embolism to the patient. to date, the manufacturer has received no reports of adverse patient events related to this issue.
  • Action
    Pyramed is advising users to immediately cease use of and quarantine the affected units. Pyramed will arrange for the return of affected devices and credit for unused devices after their return.

Device

Venture RX, OTW and CS Catheters
  • Model / Serial
    Venture RX, OTW and CS CathetersVenture RX Model Number: 5820Venture OTW Model Number: 5821Venture CS Model Number: 5882 Multiple Lot NumbersSupplied under Special Access Scheme (SAS)
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Pyramed Pty Ltd

Manufacturer

Pyramed Pty Ltd