Events

Recall of DLP Single Stage Venous Cannula with Metal Tip (Intended for the collection of deoxygenated blood from the superior and/or inferior vena cava during cardiopulmonary bypass)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Medtronic Australasia 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-2013-RN-00160-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-02-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00160-1
  • 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
    Medtronic has identified the potential for uncharacteristically rough metal edges, to occur along the inner diameter of the metal tip side ports of the cannula.
  • Action
    Medtronic is asking customers to immediately quarantine all affected products and return it to Medtronic for credit.

Device

DLP Single Stage Venous Cannula with Metal Tip (Intended for the collection of deoxygenated blood...
  • Model / Serial
    DLP Single Stage Venous Cannula with Metal Tip (Intended for the collection of deoxygenated blood from the superior and/or inferior vena cava during cardiopulmonary bypass)Model Numbers: 69324, 69328, 69331Lot Numbers: 2012121362, 2012121364, 2012121005 and 2012121063ARTG Number: 155002
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia 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