Vascular Solutions, Inc (Minneapolis, MN) has initiated a voluntary recall of the Guardian II hemostasis valves due to an increased risk of air leakage.
This leakage could lead to an air embolism which could result in serious injury or death.
The Guardian II hemostasis valve is used during catheterization procedures.
More than 26 000 devices have been manufactured, with 5283 distributed in the United States. The affected products are from lots of model numbers 8210 and 8211, which were manufactured between March 2015 and February 2016 and distributed between April 2015 and February 2016. A complete listing of the recalled lots is available from Vascular Solutions.
According to a US Food and Drug Administration (FDA) safety alert, this recall is only related to the Guardian II hemostasis valves and does not include the Guardian II NC hemostasis valves.
The FDA has classified this recall as a Class I which is defined as “a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
Healthcare professionals and patients can report adverse events or side affects to the FDA’s MedWatch Safety Information and Adverse Reporting Program.
Guardian II hemostasis valves by Vascular Solutions, Inc: recall – risk of air leakage [press release]. Silver Spring, MD: United States Food and Drug Administration; April 11, 2016.