Events

Safety Alert for BioMatrix NeoFlex

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
    2013-08-16
  • Event Date Posted
    2013-08-16
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130816.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 neoflex it has come to our attention that medical device manufacturer, biosensors, has initiated a field safety corrective action concerning its biomatrix neoflex. in specific production lots of the affected device, biosensors has received reports of hub cracking prior to or during percutaneous coronary intervention procedures. this issue is related exclusively to the delivery system hub. patients who have already been successfully implanted with an affected device are not impacted by this action. if not identified prior use, the hub cracking may potentially lead to treatment delays or complications. the manufacturer has determined that the hub cracks are associated with inconsistencies in the molding process by a single hub supplier during a limited time period in the first half of 2013. the manufacturer advises users to identify, quarantine and return affected products. according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 16 august 2013.

Device

BioMatrix NeoFlex
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Biosensors BioMatrix NeoFlex
  • Manufacturer
    Biosensors

Manufacturer

Biosensors