Atrium Medical Corporation designs, develops, manufactures, and distributes medical devices. It offers ventricular assist device components, minimally invasive gastro-intestinal devices, arterio-venous access and peripheral by-pass devices, endovascular devices, coronary and peripheral angioplasty/stent deployment catheters, artificial heart components, soft tissue repair/support components, and balloon catheter components. The company also provides online training courses that focus on emerging techniques and technologies used in the treatment of patients with complex conditions for physicians. It serves healthcare markets, including interventional cardiology and radiology, chest trauma car...
5 Wentworth Drive
Hudson, NH 03051
Founded in 1981
Federal Judge Approves Consent Decree with Maquet Holding B.V. and Co. Manufacturing Violations Cited at Three of its Medical Device Companies
Feb 4 15
A federal judge from the U.S. District Court for the District of New Hampshire has entered a consent decree of permanent injunction against Maquet Holding B.V. and Co. KG (Maquet), and two of the company's officers, Heinz Jacqui and Gail Christie, for repeatedly failing to correct violations at three of its companies, which are also named on the consent decree: Atrium Medical Corporation (Atrium); Maquet Cardiovascular, LLC (Maquet CV) and Maquet Cardiopulmonary AG (Maquet CP). Between 2009 and 2013, FDA investigators conducted ten inspections across the three Maquet facilities, and uncovered major violations of the Quality System (QS) regulation, Medical Device Reporting (MDR) regulation, and Correction and Removal (CR) regulation. During that timeframe, the agency issued two warning letters to the three companies. Additionally, between 2009 and 2014, the FDA is aware of 45 recalls of Maquet-manufactured devices, five of which were classified as Class 1 representing the most significant risk to patients. The FDA and Maquet entered into the decree to implement immediate controls, with the goal of bringing all facilities into compliance with the Federal Food, Drug and Cosmetic (FDandC) Act and its implementing regulations, including the QS, MDR, and CR regulations. Under the terms of the consent decree, Maquet will stop manufacturing and distributing devices from Atriums Hudson facility until the company makes appropriate corrections to ensure compliance with the FDandC Act. Atrium may continue to distribute certain products inside and outside of the United States that are deemed medically necessary under the decree, provided that the U.S. authorized representatives and international customers have signed a Certificate of Medical Necessity (CMN).