Events

Recall of NC Sprinter RX Balloon Dilatation Catheter ( Angioplasty balloon dilatation catheter)

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-00973-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-09-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00973-1
  • 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 a labelling issue for lot number 207002011 of the nc sprinter rx balloon dilatation catheter, model ncsp22512x, in which the compliance chart contained inside the package incorrectly references a 2.5mm balloon diameter instead of the correct 2.25mm diameter. if the affected product was utilised referencing the incorrect compliance chart, the target diameter of the balloon may be less than expected, resulting in suboptimal treatment. the situation would require further inflation at a higher pressure or the use of another balloon catheter to resolve the stenosis, resulting in longer procedural duration.
  • Action
    Medtronic is requesting users to return affected stock for replacement with unaffected product.

Device

NC Sprinter RX Balloon Dilatation Catheter ( Angioplasty balloon dilatation catheter)
  • Model / Serial
    NC Sprinter RX Balloon Dilatation Catheter ( Angioplasty balloon dilatation catheter)Model Number: NCSP22512XLot Number: 207002011ARTG 154737
  • 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