China NMPA Product Recall - artificial heart-lung machine

Terumo Cardiovascular Systems Corporation (TCVS), through its agent Terumo (China) Investment Co., Ltd., initiated a voluntary Class II recall of its System 1 Artificial Heart-Lung Machines. Reported to the National Medical Products Administration (NMPA) on October 15, 2019, and published on October 29, 2019, this action addresses a critical defect in the Electronic Gas Mixing Monitoring (EPGS) unit. It was discovered that the EPGS unit's internal flow meter provided inaccurate gas flow rate readings, potentially inconsistent with values displayed on the central monitoring display (CCM). While no patient injuries or adverse events have been reported, the potential for inaccurate monitoring during extracorporeal circulation for cardiac surgery necessitated this recall. The affected product, identified by registration number CFDA (Imported) No. 20083451664, is part of a global recall, with one unit in China requiring intervention as another was previously scrapped. Terumo (China) is implementing several corrective actions, including sending recall notices to customers and arranging engineer visits. Engineers will guide customers on using external mechanical flow meters for cross-verification, advising discontinuation of machine use if inconsistencies are found. Subsequently, the company will replace defective EPGS internal flow meters provided by TCVS and closely monitor the product's future use to ensure patient safety.