China NMPA Product Recall - Cardiopulmonary bypass system centrifugal pump

Leenopha (China) Medical Technology Co., Ltd. announced a voluntary Class III recall for its cardiopulmonary bypass system centrifugal pumps, effective September 2, 2019. This action, overseen by the National Medical Products Administration (NMPA), addresses a critical malfunction in the angle encoder located within the SCP control panel (specifically sub-devices 60-02-15 and 60-02-50). The angle encoder is vital for regulating pump speed. The core issue involves premature wear of the encoder shaft, which can impede or prevent its rotation, thereby causing the speed control knob to jam, become unresponsive, or fail to control the drive unit. The company identified a significant safety risk: during cardiopulmonary bypass procedures, this malfunction could prevent healthcare professionals from setting a specified blood flow rate. Such an inability could lead to blood flow exceeding or falling below therapeutic requirements, potentially impacting patient safety. The affected products were registered under the Shanghai Food and Drug Administration. As a required action, Leenopha (China) Medical Technology Co., Ltd. is recalling these centrifugal pumps. Further comprehensive details regarding the specific models, specifications, and batches involved are available in the accompanying "Medical Device Recall Event Report Form."