Events

Recall of Cordis SMART Flex Vascular Stent System

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

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
    21189
  • Event Initiated Date
    2017-03-10
  • 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: InterMed Medical Ltd, 71 Apollo Drive, Albany, AUCKLAND 1311
  • Reason
    Based on complaints and subsequent investigation, the manufacturer has determined that smart flex vascular stents system size 5x200mm and 6x200mm have been associated with an higher frequency of incidents of deployment difficulty.
  • Action
    Product to be returned to supplier

Device

Cordis SMART Flex Vascular Stent System
  • Model / Serial
    Model: , Affected: Lot range 34469 through 39974
  • Manufacturer
    Cordis Corporation

Manufacturer

Cordis Corporation