FDA WARNING_LETTER - Maquet Cardiopulmonary Ag - April 04, 2016

The FDA issued a Warning Letter to Maquet Cardiopulmonary AG regarding its CardioHelp System, citing violations of the Federal Food, Drug, and Cosmetic Act. The FDA determined the firm is marketing the device in the U.S. without the necessary marketing clearance or approval. Specifically, the CardioHelp System is deemed adulterated under section 501(f)(1)(B) of the Act because promotional claims on the firm's websites describe uses for which there is no approved premarket approval (PMA) or investigational device exemption. The device is also misbranded under section 502(o) and 21 C.F.R. 807.81(a)(3)(ii) due to major changes/modifications to its intended use without submitting a new premarket notification (510(k)). The cleared uses were limited to six hours for specific procedures and transport, whereas the firm promotes it for critical care, ARDS, septic shock, cardiogenic shock, and as medium/long-term therapeutic assist for various acute and chronic conditions, including medical emergencies like anaphylactic shock, trauma, and hypothermia, which typically require support exceeding six hours. Maquet Cardiopulmonary AG is required to immediately cease activities leading to misbranding or adulteration and provide a written response within fifteen business days detailing corrective actions, a prevention plan, and documentation, including a timetable for systemic corrections. The firm must also provide the basis for marketing claims related to medical emergencies. Failure to comply may impact federal contract awards.