Events

Recall of Neuroform Atlas Stent System (Used with occlusive devices in the treatment of intracranial aneurysms)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Stryker South Pacific.

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-00298-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-03-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00298-1
  • 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 neurovascular has become aware that the product labels (pouch and carton) for the neuroform atlas stent catheter contains an incorrect conversion from inches to millimetres for the minimum catheter diameter dimension (0.0165in 0.69 mm). the correct dimensions are 0.0165in (0.42mm). this labelling discrepancy could lead to a physician selecting a catheter which is too large. the hazard associated with this is that the stent would prematurely deploy during transfer into the catheter. if this happens, additional procedure/treatment would be required and the patient may be exposed to increased time under anaesthesia.
  • Action
    The sponsor is advising that the affected devices can continue to be used, provided that the correct dimensions listed in the product directions for use (DFU) are followed. This action has been closed-out on 23/01/2017.

Device

Neuroform Atlas Stent System (Used with occlusive devices in the treatment of intracranial aneury...
  • Model / Serial
    Neuroform Atlas Stent System (Used with occlusive devices in the treatment of intracranial aneurysms)Item numbers: EZAS3024, EZAS3015, EZAS4015, EZAS4530, EZAS3021, EZAS4521 and EZAS4024.All lot numbersSupplied under the Special Access Scheme
  • Manufacturer
    Stryker South Pacific

Manufacturer

Stryker South Pacific
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    DHTGA