Events

Recall of Stryker Neurovascular - III - 46352 - Neurovascular embolisation implant

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Stryker Neurovascular.

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
    19898
  • Event Initiated Date
    2016-03-18
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Stryker New Zealand Ltd, 515 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • Reason
    It was identified that the neuroform atlas pouch and carton label references the incorrect measurement in millimeters for the minimum catheter diameter. the minimum catheter diameter is correctly listed as 0.0165 inches on both product labels, but incorrectly converted to millimetres as 0.69mm. the correct conversion value is 0.42. the 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. the result to the patient being extended procedure/ additional treatment required and increased time under anaesthesia. no adverse health consequences are anticipated. there is no risk to patients associated with previous use of affected devices.
  • Action
    Manufacturer to issue advice regarding use

Device

Stryker Neurovascular - III - 46352 - Neurovascular embolisation implant

Manufacturer

Stryker Neurovascular
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    NZMMDSA