Events

Recall of Cordis S.M.A.R.T. Flex Vascular Stent System

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Cardinal Health Australia 503 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-2017-RN-01446-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-11-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01446-1
  • 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
    Cordis has determined that certain lots of the s.M.A.R.T. flex vascular stent system have a potential for cracked luer hubs, due to a manufacturing error.The luer hub is used to inject contrast/saline during procedure preparation, prior to insertion of the stent system into the patient. a cracked hub could result in leakage of saline, or in the worst case, inability to flush the outer sheath of the catheter. the potential medical consequence would be a delay in device preparation, resulting in the need to prepare a replacement device for use. cordis does not anticipate any other patient impact.
  • Action
    Cordis is advising users to inspect stock and quarantine any remaining units of the affected product for return.

Device

Cordis S.M.A.R.T. Flex Vascular Stent System

Manufacturer

Cardinal Health Australia 503 Pty Ltd