Events

Recall of Cordis PRECISE PRO Rx Nitinol 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
    20148
  • Event Initiated Date
    2016-05-11
  • 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: Johnson & Johnson Medical New Zealand Ltd, 507 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • Reason
    Based on complaints and subsequent investigation, the manufacturer has detected an increased frequency of users reporting difficulty with stent deployment and/or separation of the bond between sections of the device outer member., the manufacturer has isolated the issue to product manufactured between april 27, 2015 and november 22, 2015. product that has been manufactured after november 22, 2015, is not affected.
  • Action
    Product to be destroyed

Device

Cordis PRECISE PRO Rx Nitinol Stent System
  • Model / Serial
    Model: Multiple lot numbers, Affected: Product manufactured between April 27, 2015 and November 22, 2015.
  • Manufacturer
    Cordis Corporation

Manufacturer

Cordis Corporation