Events

Recall of Mirage, Silverspeed, X-celerator & X-pedion Guidewires, Hyperform & Hyperglide Occlusion Balloon Catheters and Guidewires (Supplied in Procedure Packs)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by EV3 Australia Pty Limited.

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-00717-3
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-07-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00717-3
  • 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 a regulatory compliance issue where the guidewires were included in the australian register of therapeutic goods (artg) as class iia medical device. they should have been included as class iii. the hyperform and hyperglide occlusion balloon catheters, which are currently supplied in procedure packs also contain one of the above-mentioned guidewires. it has come to the attention of ev3 that these systems have not been included in the artg.
  • Action
    Quarantine affected stock. The use of affected microcatheters should be only limited to patients eligible under the Special Access Scheme.

Device

Mirage, Silverspeed, X-celerator & X-pedion Guidewires, Hyperform & Hyperglide Occlusion Balloon ...
  • Model / Serial
    Mirage, Silverspeed, X-celerator & X-pedion Guidewires, Hyperform & Hyperglide Occlusion Balloon Catheters and Guidewires (Supplied in Procedure Packs)
  • Manufacturer
    EV3 Australia Pty Limited

Manufacturer

EV3 Australia Pty Limited
  • 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