Events

Safety Alert for BioMatrix Flex and BioMatrix NeoFlex Coronary Drug Eluting Stent Systems

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

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
    2016-03-02
  • Event Date Posted
    2016-03-02
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160302a.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: biosensors biomatrix flex and biomatrix neoflex coronary drug eluting stent systems medical device manufacturer, biosensors, has issued a medical device safety alert concerning its biomatrix flex and biomatrix neoflex coronary drug eluting stent systems. the manufacturer is initiating a voluntary recall on certain units of biomatrix flex and biomatrix neoflex coronary drug eluting stent system (des) due to potential balloon burst below the rated burst pressure. the manufacturer discovered during routine lot release testing that several production lots did not meet the balloon rated burst performance specifications. after full investigation, the manufacturer concludes that the compromised balloon performance was caused by certain characteristics in the manufacturing process. according to the manufacturer, the production lots manufactured between october to december 2015 could have been similarly affected. the compromised balloon performance may potentially lead to delay in inflation or deflation of the balloon; or balloon burst when the balloon is inflated above the nominal pressure. this could result in procedural complications and lead to serious deterioration in the patient’s state of health during percutaneous coronary intervention. patients who have already been implanted with an affected device are not impacted by this field safety corrective action. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 2 march 2016.

Device

BioMatrix Flex and BioMatrix NeoFlex Coronary Drug Eluting Stent Systems
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Biosensors BioMatrix Flex and BioMatrix NeoFlex Coronary Drug Eluting Stent Systems
  • Manufacturer
    Biosensors

Manufacturer

Biosensors