Events

Recall of Catheters with Beacon Tip Technology

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by William A Cook 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-2016-RN-00483-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-04-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00483-1
  • 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
    Cook medical has identified an increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. the preliminary investigation has identified that environmental conditions, such as storage temperature, humidity, and the use of vaporised hydrogen peroxide (vhp) for whole-room decontamination within healthcare facilities, may be contributing to the occurrence. it is recognised that there may be other undetermined contributors to this issue and continue to investigate. potential adverse events that may occur as a result of catheter polymer degradation include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. fragments within the vascular system could result in embolisation to the heart or lungs, or occluding blood flow to end organs.
  • Action
    Cook Medical is advising users to quarantine and return any unused product.

Device

Catheters with Beacon Tip Technology
  • Model / Serial
    Catheters with Beacon Tip TechnologyMultiple products/catalogue numbers affectedAll lots affectedARTG Numbers: 137861, 154909, 153374, 153375,154911, 137861, 214869, 137911, 212573,133996, 208185, 207779
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd