China NMPA Product Recall - Artificial Heart-Lung Machine - Heat Exchange Water Tank

Terumo Cardiovascular Systems Corporation initiated a Class II voluntary recall of its artificial heart-lung machine heat exchange tanks, including models TCM II and HX2, impacting 104 units sold in China. This action, published by the National Medical Products Administration (NMPA) on January 24, 2019, stems from an ongoing US FDA investigation into nontuberculous mycobacterial (NTM) infections associated with heat exchanger equipment. The core issue is the potential for NTM to proliferate within the heat exchanger water tanks. Although the water does not directly contact patient blood, contaminated water droplets can atomize and disperse into the operating room air, posing a risk of infection or other adverse events during open-chest surgery, particularly for cardiovascular patients. In response, Terumo (China) Investment Co., Ltd. has revised and updated its cleaning guidelines for the affected Sarns® heat exchange equipment. The company's required actions include distributing these new guidelines to 63 hospitals across China, encompassing 72 units still in use. Furthermore, Terumo committed to monitoring the hospitals' implementation of these updated cleaning protocols and providing hands-on guidance from after-sales service personnel as needed to ensure proper adherence and minimize patient risk.