Events

Safety Alert for Guardian II Hemostasis Valve

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

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
    2016-03-30
  • Event Date Posted
    2016-03-30
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160330b.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: vascular solutions guardian ii hemostasis valve the medicines and healthcare products regulatory agency (mhra) of united kingdom posted a medical device safety alert concerning guardian ii hemostasis valve manufactured by vascular solutions. the affected model numbers are fh101, fh101-t, fh101-25 and fh101-50. the affected lot numbers are 41817, 42029, 42068, 42409, 42410, 42687, 42688, 42689, 42691, 42692, 42693, 42699, 42700, 42701, 42986, 42987, 42988, 42989, 43186, 43187, 43188 and 43408. investigation of a recent complaint has made the manufacturer aware of a potential problem with the click version of the guardian ii hemostasis valve. the low pressure seal may not close properly, which may allow air to be introduced into the device and may lead to risk of an air embolism. according to the manufacturer, no air ingress or patient harm has been reported. the manufacturer advises affected users to identify and remove all affected devices. for details, please refer to the mhra website: https://www.Gov.Uk/drug-device-alerts/field-safety-notices-21-march-to-25-march-2015 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 30 march 2016.

Device

Guardian II Hemostasis Valve

Manufacturer

Vascular Solutions