05.01.13
Vascular Solutions Zerusa Ltd., a subsidiary of Vascular Solutions Inc., voluntarily has recalled its Guardian II and Guardian II NC hemostasis valves in the United States. The devices are used in catheterization processes. Specific lots of the products have been recalled because they pose a slightly increased risk of air leakage that may lead to an air embolism, which could result in serious injury or death. The recalled products were manufactured from February 2012 to February 2013 and distributed in the same period.
The company has advised that healthcare facilities that have the affected devices remove the products from their inventory and return them to Vascular Solutions.
Vascular Solutions Zerusa Ltd. initiated the recall on Feb. 28 through an Urgent Medical Device Recall notification distributed to purchasers of the affected products. Vascular Solutions Inc. in turn notified its customers of the specific lots subject to the recall and included instructions on how to return the affected products.
The company claims no injuries have been reported in association with this issue, but the U.S. Food and Drug Administration (FDA) MAUDE database records show an adverse event occurred on Feb. 14 in which an air embolism was introduced while using a Guardian II hemostasis valve during a clinical procedure.
The FDA has classified this as a Class I recall. FDA defines Class I recalls as “a situation in which there is a reasonable probability that the use of or exposure to the violative product will cause serious adverse health consequences or death.”
Vascular Solutions makes devices for coronary and peripheral vascular procedures, and is headquartered in Minneapolis, Minn. Vascular Solutions Zerusa was created when Vascular Solutions acquired the Guardian hemostasis valve assets from Zerusa Ltd. The subsidiary is based in Galway, Ireland.
The company has advised that healthcare facilities that have the affected devices remove the products from their inventory and return them to Vascular Solutions.
Vascular Solutions Zerusa Ltd. initiated the recall on Feb. 28 through an Urgent Medical Device Recall notification distributed to purchasers of the affected products. Vascular Solutions Inc. in turn notified its customers of the specific lots subject to the recall and included instructions on how to return the affected products.
The company claims no injuries have been reported in association with this issue, but the U.S. Food and Drug Administration (FDA) MAUDE database records show an adverse event occurred on Feb. 14 in which an air embolism was introduced while using a Guardian II hemostasis valve during a clinical procedure.
The FDA has classified this as a Class I recall. FDA defines Class I recalls as “a situation in which there is a reasonable probability that the use of or exposure to the violative product will cause serious adverse health consequences or death.”
Vascular Solutions makes devices for coronary and peripheral vascular procedures, and is headquartered in Minneapolis, Minn. Vascular Solutions Zerusa was created when Vascular Solutions acquired the Guardian hemostasis valve assets from Zerusa Ltd. The subsidiary is based in Galway, Ireland.