Events

Field Safety Notices about Guardian® II Hemostasis Valve

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Vascular Solutions, Inc..

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
  • Extra notes in the data
  • Reason
    Investigation of a recent complaint has made vascular solutions, inc. aware of a potential problem with the click version of our 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. no air ingress or patient harm has been reported; however, due to the potential harm vsi is voluntarily recalling guardian ii hemostasis valves manufactured with the following lot number(s): .

Device

Guardian® II Hemostasis Valve

Manufacturer

Vascular Solutions, Inc.