Events

Recall of Stryker Neurovascular Excelsior SL-10/Excelsior 1018 Microcatheters

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Stryker 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-2015-RN-00485-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-06-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00485-1
  • 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
    Stryker has become aware that certain lots of the above excelsior sl-10/excelsior 1018 microcatheters have incorrect product expiry dates printed on the packaging. the earliest expiration date of the affected products is may 2016. in the event these products remain in the market after the labelled expiry date, there is a potential hazard that patients exposed to this product may experience severe health consequences.
  • Action
    Stryker is requesting their customers to quarantine any affected lots on hand. Any affected items will be removed by the Stryker Representative and customers will be provided with unaffected replacement stock. This action has been closed-out on 18/08/2016.

Device

Stryker Neurovascular Excelsior SL-10/Excelsior 1018 Microcatheters
  • Model / Serial
    Stryker Neurovascular Excelsior SL-10/Excelsior 1018 MicrocathetersExcelsior SL-10 150CM 2 TIPExcelsior 1018 Pre-shaped 45 150CMExcelsior SL-10 Pre-shaped 45 150CMExcelsior SL-10 Pre-shaped 90 150CMExcelsior SL-10 Pre-shaped J 150CMCatalogue Numbers: 168189, 144190, 168190, 168191, 168192Lot Numbers: 17026669, 17013156, 17013021,17026849, 17030892, 17045869, 17045959, 17046094, 17046274, 17046229ARTG Numbers: 177031, 149440, 147430
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    DHTGA