China NMPA Product Recall - Blood flow diversion embolization device

On August 10, 2021, Covidien Medical Devices International Trading (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its flow diverting embolization devices. This action was taken in response to reports of fractured distal push wires within the Pipeline Flex delivery system during use. Investigations revealed a defect in raw materials from a specific manufacturing batch, causing fractures in the helical cut area of the hypo tube. This critical issue can lead to device malfunction and potentially result in adverse events for patients. The recall was reported through the Shanghai Municipal Drug Administration Website and overseen by the National Medical Products Administration (NMPA) as part of its regulatory framework for medical devices. Covidien Medical Devices International Trading (Shanghai) Co., Ltd. is actively recalling the affected products to ensure patient safety and compliance with medical device regulations. Detailed information regarding the specific models, specifications, and batches is available in the associated "Medical Device Recall Event Report Form."