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February 3, 2015

Posted  January 25, 2016

Medical device maker Atrium Medical Corporation, Maquet Holding B.V. & Co. KG, Maquet Cardiovascular LLC, and Maquet Cardiopulmonary AG were permanently enjoined from distributing adulterated and misbranded medical devices. According to the government, Atrium — which manufactures medical devices for cardiovascular-related uses, including chest drains, surgical meshes, vascular grafts and stent systems — was not complying with the FDA’s current good manufacturing practice requirements for medical devices which are designed to ensure the devices are safe and effective and otherwise in compliance with the federal Food, Drug and Cosmetic Act. DOJ

Tagged in: CGMP Violation, Defective Products, Medical Devices and DME,