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