China NMPA Product Recall - Intra-aortic balloon counterpulsation pump

Maikewei (Shanghai) Medical Equipment Co., Ltd. initiated a voluntary Class III recall for its Intra-Aortic Balloon Counterpulsation Pumps, as announced by the National Medical Products Administration (NMPA) on January 13, 2017. The recall was prompted by a significant safety concern identified with the product's lithium batteries. The company discovered that if these batteries are accidentally dropped, they may generate smoke, emit odors, and produce sparks, posing potential hazards to users and the surrounding environment. To address this issue, Maikewei (Shanghai) Medical Equipment Co., Ltd. is undertaking specific corrective actions. These include the placement of prominent warning labels directly on the lithium batteries to alert users to the identified risk. Additionally, the company is actively communicating with users, providing crucial reminders to exercise caution and prevent the dropping of these batteries during handling or operation. Further details regarding the specific models, specifications, and batches affected by this recall are available in the accompanying "Medical Device Recall Event Report Form." This action highlights the company's commitment to product safety under the NMPA's oversight.