Events

Recall of Medtronic MiniMed Sure-T infusion sets

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-2015-RN-00506-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-06-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00506-1
  • 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 identified that certain minimed sure-t infusion sets had a slight increase of reported cases where the steel needle broke during use. in a small number of these reported cases, the needle break led to hospitalisation for the management of glucose levels and/or treatment for removal of the needle. since then, an improvement in the needle manufacturing was implemented, which has reduced the number of reported cases of needle breaks.
  • Action
    In the event consumers wish to carry on with using the old needle they are reminded to follow the current IFU along with specific additional instructions in the customer letter; OR if they prefer users (including members of the public) can phone Medtronic for replacement with unaffected stock. For more details, please see https://www.tga.gov.au/alert/medtronic-minimed-sure-t-infusion-sets. This action has been closed-out on 12/08/2016.

Device

Medtronic MiniMed Sure-T infusion sets
  • Model / Serial
    Medtronic MiniMed Sure-T infusion setsModel Numbers: MMT-860, MMT-862, MMT-863, MMT-864, MMT-865, MMT-866, MMT-870, MMT-873, MMT-874, MMT-875, MMT-876, MMT-883, MMT-884, MMT-885, MMT-886ARTG # 119216
  • 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