China NMPA Product Recall - Blood flow diversion embolization device

Covidien Medical Devices International Trading (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its Flex flow diverter embolization devices on September 23, 2020. This action was prompted by reports of intraoperative breakage and dissociation of the device, which could lead to potential patient injury, particularly when used in tortuous vessels or encountering excessive resistance. The company is taking two primary actions: recalling affected devices (Registration Certificate No.: 20173772468) and updating the product information leaflet. The updated leaflet will clearly communicate the possibility of device breakage or dissociation and the associated patient risks under specific conditions. This recall is overseen by the National Medical Products Administration (NMPA) in China, demonstrating the regulatory body's role in ensuring medical device safety and the company's commitment to product transparency and patient well-being.