China NMPA Product Recall - Indy OTV Retriever intravascular capture device

The National Medical Products Administration (NMPA) issued an announcement on April 25, 2024, regarding a voluntary Class III recall initiated by Cook Incorporated for its Indy OTV Retriever intravascular grabbing device. Cook (China) Medical Trading Co., Ltd. reported this action, which was prompted by identified differences between the affected product and the specific regulatory approval requirements stipulated for the Japanese market. This recall is a proactive measure taken by Cook Incorporated to ensure compliance with distinct international market standards. While the device holds a National Medical Device Registration Certificate (No. 20163032259) in China, the discrepancies emerged concerning its adherence to Japanese market-specific regulations. The recall level, Class III, signifies that while a deviation from regulatory requirements has been identified, the use of or exposure to the product is not likely to cause adverse health consequences. The required action involves the systematic retrieval of the non-compliant Indy OTV Retriever devices. Detailed information regarding the models, specifications, and batch numbers of the affected products has been provided in the accompanying Medical Device Recall Event Report Form, ensuring transparency and facilitating the effective execution of the recall process across relevant distribution channels. This demonstrates the company's commitment to maintaining rigorous product standards and adhering to diverse global regulatory landscapes.