Events

Recall of Lifestent Vascular Stent System (200 mm stent length)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Bard Australia 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-01038-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-10-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01038-1
  • 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
    After successful introduction of an optimised delivery system design, the device manufacturer angiomed has determined that the optimised lifestent solo vascular stent systems have a significantly lower incidence rate of partial stent deployment associated with their use compared to the original lifestent vascular stent system. the manufacturer, angiomed, has determined that due to the number of lifestent vascular stent system original design devices still available in consignment and customer inventory positions, and the improved performance of the lifestent solo vascular stent system optimized design, a recall action related to the original design product is warranted. this measure will provide customers and patients the lifestent solo optimized stent delivery system performance.
  • Action
    Customers are requested to inspect their stock and quarantine any product from the affected lots. Bard will arrange for the return and replacement of affected stock. No medical or surgical interventions and no monitoring measures are required for LifeStent Vascular Stents which have already been implanted, as the reported partial stent deployments occurred during the release of the stent from the delivery system.

Device

Lifestent Vascular Stent System (200 mm stent length)
  • Model / Serial
    Lifestent Vascular Stent System (200 mm stent length)Product Code: EX072001L, EX072003L Lots: ANVK0073, ANWB0773, ANWC3759, ANWC3760ARTG: 160453
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd