Events

Recall of Cordis PRECISE PRO RX Nitinol Stent System (Carotid)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Johnson & Johnson Medical Pty Ltd.

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-00625-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-05-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00625-1
  • 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
    Based on complaints and a 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 reported issues may result in an intra-procedural delay for the patient while a replacement device is prepped. partial stent deployment may result in vessel damage (carotid dissection or perforation, vessel spasm) requiring unplanned percutaneous or surgical intervention to prevent permanent injury or impairment. in most severe cases, partial stent deployment may potentially result in transient ischaemic attack or stroke.Cordis have isolated the issue to product manufactured between 27 april 2015 and 22 november 2015. product that has been manufactured after 22 november 2015 is not affected.
  • Action
    Users are asked to immediately identify and quarantine all products listed in the customer letter in a manner that ensures the affected products will not be used and to complete the attached acknowledgement form, follow the instructions given and to forward this notice to anyone in your facility that needs to be informed. This action has been closed-out on 04/05/2017.

Device

Cordis PRECISE PRO RX Nitinol Stent System (Carotid)

Manufacturer

Johnson & Johnson Medical Pty Ltd