China NMPA Product Recall - Intra-aortic balloon counterpulsation pump

Terif Medical Devices Trading (Shanghai) Co., Ltd. initiated a voluntary Class I recall of its Intra-Aortic Balloon Counterpulsation Pumps (IABP), specifically models AutoCAT 2 and AutoCAT 2 WAVE, as detailed in a recall notice issued on June 1, 2020, by the Shanghai Municipal Drug Administration. This action addresses a significant product defect where a critical component within the pump is prone to vibration-induced failure. The identified issue involves micro-wear, carbonization, and discoloration of the motor connector wiring. This degradation can lead to the display of "System Error 3" and "High Baseline" alarms, potentially causing the pump to stop operating abruptly or fail to start altogether. While no injuries or patient complications directly linked to this specific defect have been reported, and devices have not stopped without displaying the preceding alarms, the potential for serious harm necessitates this high-level recall. The recall is being managed under the oversight of the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration, highlighting the stringent regulatory framework governing medical devices in China. The company is actively retrieving affected units to mitigate any risk to patient safety. Further details regarding specific product models, specifications, and batch numbers are available in the accompanying "Medical Device Recall Event Report Form."