Events

Recall of CONMED Concept Heatwave Electrode, 130mm x 2.3mm diameter (5 per box) (electrosurgical electrode used for ablation of soft tissue and coagulation of vessels)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by ConMed Linvatec 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-01129-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-08-26
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01129-1
  • 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 has received complaints of damage to the electrode shaft insulation, which could increase the risk of a patient burn.To date, conmed has not received any reports where this has led to illness or injury.
  • Action
    ConMed Linvatec is advising users to immediately discontinue use of the affected product and to return it to ConMed Linvatec for credit or replacement. This action has been closed-out on 10/05/2017.

Device

CONMED Concept Heatwave Electrode, 130mm x 2.3mm diameter (5 per box) (electrosurgical electrode ...
  • Model / Serial
    CONMED Concept Heatwave Electrode, 130mm x 2.3mm diameter (5 per box) (electrosurgical electrode used for ablation of soft tissue and coagulation of vessels)Reference/Catalogue Number: CS-023Affected Lots: 267221 to 695063ARTG Number: 94017
  • Product Classification
    General and Plastic Surgery Devices
  • Manufacturer
    ConMed Linvatec Australia Pty Ltd

Manufacturer

ConMed Linvatec Australia Pty Ltd