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News Breaks | | | | March 15, 2013 | | 16:32 EDT |  | VASC | Vascular Solutions issues recall of Guardian II, Guardian II NC valves
On February 28, Vascular Solutions Zerusa, a subsidiary of Vascular Solutions (VASC), initiated a nationwide recall of Guardian II and Guardian II NC hemostasis valves used in catheterization procedures. 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. No injuries have been reported in association with this issue. The U.S. Food and Drug Administration 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." | |
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News For VASC From The Last 14 Days Check below for free stories on VASC the last two weeks. |
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| May 16, 2013 | | 16:13 EDT | | VASC | Vascular Solutions files patent infringement complaint against Boston Scientific
Vascular Solutions (VASC) announced that it has filed a patent infringement complaint in the U.S. District Court for the District of Minnesota against Boston Scientific Corporation (BSX). The complaint alleges that Boston Scientific has infringed three patents owned by Vascular Solutions concerning rapid exchange guide extension technology by manufacturing and selling its Guidezilla guide extension catheter which received 510(k) clearance in March. Vascular Solutions is seeking an injunction against Boston Scientific prohibiting the manufacture and sale of its Guidezilla catheter as well as damages for lost profits and legal costs. | |
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