Events

Recall of ARRIVE Braided Transseptal Sheath

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-2016-RN-01432-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-11-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01432-1
  • 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 was recently notified that the manufacturer, oscor has initiated a product recall for certain lots of their adelante breezeway 8f & 10f sheaths due to a potential for "a fragment of the sheath inner liner to come off during the insertion of the dilator during the preparation of the sheath prior to use." medtronic sells the oscor adelante breezeway 10f product as the arrive braided transseptal sheath. oscor has received one complaint related to this issue, which did not result in patient injury. however, the risk for possible injury is a concern if the sheath is not properly flushed and tested with the dilator prior to use.
  • Action
    Customers are advised to immediately quarantine and return all affected stock. Medtronic Customer Service Representative will organise the return and replacement of unused products. For affected product that has been used, no action is necessary and patients should continue to be managed in accordance with the standard patient management protocol.

Device

ARRIVE Braided Transseptal Sheath
  • Model / Serial
    ARRIVE Braided Transseptal Sheath Model Numbers: 990061-055, 990061-070, 990061-090, 990061-120, 990079-055, 990079-070, 990079-090Multiple Lot NumbersARTG Number: 202067
  • 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