Events

Safety Alert for S.M.A.R.T. ® CONTROL® Nitinol Stent System

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Cordis.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2012-02-01
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120202c.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Field safety notice: cordis s.M.A.R.T. ® control® nitinol stent system medical device manufacturer, cordis, a johnson & johnson company, has issued a field safety notice on cordis s.M.A.R.T. ® control® nitinol stent system product. cordis has identified a potential sterility breach in the pouches of all unexpired lots (lot number 15525516 and below) of cordis s.M.A.R.T. ® control® nitinol stent system product with the 65 catalog numbers. cordis revealed that the potential defect was detected during in-house testing on non-production product as part of a development project. further investigation determined that conditions leading to a potential pathway through the seal exist in a small percentage of distributed products. since the compromised seal is not readily apparent to the unaided eye and using of a non-sterile device may expose the patient to increased risk of infection, cordis has decided to recall the product. according to the local supplier, the affected product has been distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions.

Device

S.M.A.R.T. ® CONTROL® Nitinol Stent System
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Cordis S.M.A.R.T. ® CONTROL® Nitinol Stent System
  • Manufacturer
    Cordis

Manufacturer

Cordis