Events

Recall of Transseptal Needle

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-2017-RN-01503-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-12-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01503-1
  • 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 become aware that certain transseptal needles may be the incorrect length, and is initiating a recall of lot 8181945. potential adverse events may occur by using the nonconforming products, including being unable to perform the transseptal puncture. this could necessitate replacing the device or rescheduling the procedure. in addition, use of the nonconforming products could make the puncture less controlled, which could potentially lead to injury of the heart.
  • Action
    Cook Medical is advising customers to quarantine affected stock from their inventory for return to the sponsor for a product credit as per the instructions given in the customer letter.

Device

Transseptal Needle
  • Model / Serial
    Transseptal NeedleLot Number: 8181945Reference Part Number: TSNC-18-71.0Global Part Number: G02364ARTG 155227
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd