Events

Safety Alert for BioPath 035

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

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
    2015-02-23
  • Event Date Posted
    2015-02-23
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150223d.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 international biopath 035 medical device manufacturer, biosensors international, has issued a field safety notice concerning biopath 035, with the following details: model bpth-35-60100l (balloon diameter 6.0 x 100mm length – catheter length 135cm) all lot numbers for this model manufactured prior to november 2014 are affected. the manufacturer has received a report regarding a compatibility issue with the recommended sheath introducer size. the product is currently labelled for a 5f sheath introducer compatibility when the product specification is indicating a 6f recommendation. according to the manufacturer, this mislabeling has no impact on patient safety but it may lead to a prolonged procedure. patients who have already been successfully treated with an affected device are not impacted by this action. the manufacturer advises users to identify and quarantine the affected products. they will contact the affected users to arrange the corrective action. according to the local supplier, the affected product is distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 23 february 2015.

Device

BioPath 035
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Biosensors International BioPath 035
  • Manufacturer
    Biosensors International

Manufacturer

Biosensors International