China NMPA Product Recall - MEGA Intra-Aortic Balloon Catheters and Accessories

Datascope Corp. has initiated a voluntary Class III recall of its MEGA Intra-Aortic Balloon Catheters and associated accessories. The recall, reported by Maikewei (Shanghai) Medical Equipment Co., Ltd. to the National Medical Products Administration (NMPA) on October 17, 2024, stems from critical inconsistencies identified between the inner and outer packaging labels of the affected devices. This labeling discrepancy necessitates corrective action under regulatory standards to ensure product identification accuracy. The regulatory framework overseeing this action is the National Medical Products Administration, which monitors medical device compliance and safety. Datascope Corp. confirmed that the specific batches of products involved in this event were not imported into the Chinese market. The required action involves a comprehensive voluntary recall process, with specific models, specifications, and batch details further outlined in the "Medical Device Recall Event Report Form." This proactive measure by Datascope Corp. aims to uphold product integrity and adherence to labeling regulations, preventing potential misidentification or misuse of medical devices.