Vascular Solutions Recalls Products Over Safety Risk
Due to potential safety issues, Maple Grove-based medical device company Vascular Solutions recently recalled two of its valve products that are used in catheterization procedures.
The company said that its subsidiary, Vascular Solutions Zerusa, Ltd., initiated a nationwide recall of its Guardian II and Guardian II NC hemostasis valves. The products are used in catheterization procedures to allow the simultaneous placement of multiple devices in an artery, and they are designed to minimize blood loss.
The recalled products, which were manufactured and distributed between February 2012 and February 2013, “pose a slightly increased risk of air leakage that may lead to an air embolism, which could result in serious injury or death,” the company said. An embolism refers to the obstruction of an artery.
No injuries have been reported in relation to the problem, according to Vascular Solutions.
The recall was classified as “Class 1” by the U.S. Food and Drug Administration (FDA), which defines such recalls as involving “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.”
Shares of the company’s stock slid 2.3 percent Friday, the day that it issued a press release regarding the recall, to close at $15. Its shares dropped another 2.3 percent Monday to close at $14.65.
This is not the first time that the Guardian product has come under scrutiny: Some models of the valve were included in a “Class II” recall in September; Class II recalls occur when use of a product could cause “temporary or medically reversible adverse health consequences,” or when “the probability of serious adverse health consequences is remote,” according to the FDA’s website.
That recall was prompted when Vascular Solutions became aware that missing seals could pose the risk of product contamination, according to the FDA.
Vascular Solutions’ portfolio includes more than 70 products and services under three primary product categories: catheter, hemostat, and vein products.
Vascular Solutions became the exclusive U.S. distributor of Zerusa Limited’s Guardian hemostatic valve in 2007 and subsequently acquired “substantially all” of Zerusa’s assets in 2011, including the Guardian products. The deal formed the Vascular Solutions Zerusa subsidiary, which is based in Ireland and initiated the recent product recall.
Vascular Solutions is one of Minnesota’s 70 largest public companies based on revenue, which totaled $98.4 million in 2012. Catheter products accounted for about 63 percent of Vascular Solutions’ sales in 2012, although the Guardian products accounted for less than $3 million, according to regulatory filings.
Health care facilities that have the recalled valves have been asked to remove them from their inventories and return them to Vascular Solutions. To view the list of model numbers included in the recall, click here.