Events

Recall of DGPHP RFA High-Power single use grounding pads and Cool-tip RFA Electrode Kits (containing DGPHP RFA High-Power single use grounding pads), Dispersive electrode used during radiofrequency lesioning procedures)

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-2012-RN-00810-3
  • Event Risk Class
    Class I
  • Event Initiated Date
    2012-08-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00810-3
  • 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
    There is the potential for foil degradation on the dgp-hp rfa high power single use grounding pads. this foil degradation may result in an electrical disconnect and an undesirable thermal profile during use which may result in a patient burn at the pad site.
  • Action
    Covidien is recalling the affected lots and replacing it with unaffected stock.

Device

DGPHP RFA High-Power single use grounding pads and Cool-tip RFA Electrode Kits (containing DGPHP ...
  • Model / Serial
    DGPHP RFA High-Power single use grounding pads and Cool-tip RFA Electrode Kits (containing DGPHP RFA High-Power single use grounding pads), Dispersive electrode used during radiofrequency lesioning procedures)Multiple Lot NumbersMultiple Product NumbersARTG Numbers: 178570 and 178245
  • Product Classification
    General and Plastic Surgery 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