China NMPA Product Recall - Intra-Aortic Balloon Pump, Intra-Aortic Balloon Catheters and Accessories, 7.5 Fr. IAB and Accessories, Plus Intra-Aortic Balloon Catheters

The National Medical Products Administration (NMPA) announced a voluntary Class III recall initiated by Datascope Corp., reported by Maikewei (Shanghai) Medical Equipment Co., Ltd., on April 3, 2025. The primary issue driving this recall is the lack of instruction manuals in the language of the sales location for several medical devices. Affected products include the Intra-Aortic Balloon Pump, Intra-Aortic Balloon Catheters (7.5 Fr. IAB and Accessories), and Plus Intra-Aortic Balloon Catheters, all holding National Medical Device Registration Certificates. This non-compliance with regulatory standards regarding product documentation could impede proper device use and patient safety. Datascope Corp. undertook this voluntary action to address the deficiency. It is important to note that the specific product models and batches involved in this recall were not imported into the Chinese market. Further details are provided in the accompanying "Medical Device Recall Event Report Form." This recall emphasizes the importance of adhering to global regulatory requirements for product labeling and user instructions.