Events

Recall of Wingman35 Crossing Catheters

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Diverse Devices 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-00578-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-05-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00578-1
  • 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 reflow medical, has identified specific lots of wingman35 crossing catheters may be prone to tip detachment. if a catheter tip detaches from the wingman 35 crossing catheter within the vasculature, it could cause injuries to blood vessel walls, thrombotic events, foreign body embolisation, heart attacks and death. the manufacturer has received no reports of injury or death associated with the tip failures.
  • Action
    Diverse Devices is advising users to stop using and quarantine all affected products. Affected products are to be returned to Diverse Devices for replacement.

Device

Wingman35 Crossing Catheters
  • Model / Serial
    Wingman35 Crossing CathetersWingman 35 Crossing Catheter, 65cmReference: WGM35065CELot Numbers: 15087074R1Wingman 35 Crossing Catheter, 90cmReference: WGM35090CELot Numbers:1505144R, 1508264, 1603214R2, 1605194RWingman 35 Crossing Catheter, 135cmReference: WGM35135CELot Numbers: 1505264, 1508204, 1604213R, 160620RARTG Number: 246377
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Diverse Devices Pty Ltd

Manufacturer

Diverse Devices Pty Ltd