Events

Recall of Medtronic CareLink 2090 Programmer (Implantable pacemaker programmer)

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-01024-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2013-10-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01024-1
  • 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 that a small subset of 2090 programmers have an incorrect software configuration for the country in which that are physically located. when a programmer is manufactured, it is configured for the region in which it will be located. in this way, medtronic is able to differentiate the timing of software updates across different regions of the globe. through the investigation of this issue, a small subset of programmers have been determined to be physically located in a country outside of the region for which they are configured.
  • Action
    Medtronic is requesting users to return affected devices for re-configuration. Medtronic representative will contact customers to coordinate the servicing and return of the programmer.

Device

Medtronic CareLink 2090 Programmer (Implantable pacemaker programmer)
  • Model / Serial
    Medtronic CareLink 2090 Programmer (Implantable pacemaker programmer)Affected serial numbers: PKK010877R, PKK054660RARTG Number: 116038
  • 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