Events

Recall of Synchro 2 Guidewire

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
    23174
  • Event Initiated Date
    2018-06-20
  • 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
    The manufacturer has become aware that the product labels (pouch and carton) for synchro 2 products contain an incorrect value in millimetres (0.036mm) for the guidewire outer diameter dimension. the inches dimension (0.014in) on the label is correct. the correct values are 0.014in (0.36mm). 0.036mm represents a typographical error.
  • Action
    Manufacturer to issue advice regarding use

Device

Synchro 2 Guidewire
  • Model / Serial
    Model: SYNCHRO 2/14 200 CM STANDARD, SYNCHRO 2/14 200 CM SOFT, SYNCHRO 2/14 300 CM STANDARD, SYNCHRO 2/14 300 CM STANDARD, Affected:
  • Manufacturer
    Stryker Neurovascular

Manufacturer

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