Events

Recall of Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes, Pre-connect (used in conjunction with Automatic External Defibrillators) Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Covidien 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-2015-RN-00803-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-08-31
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00803-1
  • 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
    This recall is being conducted due to a low-level potential for damage to the wire insulation which was identified during a review of our manufacturing process. no complaints for this issue have been reported from customers. the use of products with this condition may result in a potentially increased risk for either reduced or no patient therapy, arcing of current, sparking, and potential burns to the patient and/or clinician. no patient injuries have been reported regarding this damaged wire insulation issue.
  • Action
    Users are asked to immediately quarantine and discontinue use of the affected devices and to arrange return as per the instructions supplied. This action has been closed-out on 31/08/2016.

Device

Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes, Pre-connect (used in conjuncti...
  • Model / Serial
    Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes, Pre-connect (used in conjunction with Automatic External Defibrillators)Medi-Trace Cadence Adult Multi-Function Defibrillation ElectrodesItem Numbers: 22550PC, 22770PCLot Numbers: 517521X, 519835X, 516313X, 519124X, 513426X ARTG Number: 186124
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Covidien Pty Ltd

Manufacturer

Covidien Pty Ltd
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DHTGA