Events

Safety Alert for Ultraflex Tracheobronchial Covered Distal Release Stent System

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

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
    2016-03-22
  • Event Date Posted
    2016-03-22
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160322b.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
    Medical device safety alert: boston scientific ultraflex tracheobronchial covered distal release stent system medical device manufacturer, boston scientific, has issued a medical device safety alert concerning ultraflex tracheobronchial covered distal release stent system [material number: m00576550; lot number: 18876596; expiration date range: 1 february 2018]. the manufacturer has become aware that the incorrect stent size has been packaged in a single lot of ultraflex tracheobronchial covered distal release stents labeled with 12mm outer diameter. the use of an undersized diameter stent may increase the risk of stent migration in a stent that is not intended to be removed. if the stent were to migrate the tracheobronchial stricture may not be effectively dilated and the patient may experience coughing, difficulty breathing and tissue damage. in addition, the removal of the migrated stent may require an additional procedure. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions posted on 22 march 2016.

Device

Ultraflex Tracheobronchial Covered Distal Release Stent System
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Boston Scientific Ultraflex Tracheobronchial Covered Distal Release Stent System
  • Manufacturer
    Boston Scientific

Manufacturer

Boston Scientific
  • Manufacturer Parent Company (2017)
    Boston Scientific
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DH