China NMPA Product Recall - Cardiac output and pressure monitoring sensor (CO and pressure monitoring sensor), disposable pressure transducer, cardiac output and pressure monitoring sensor (IQ sensor), disposable pressure transducer.

The National Medical Products Administration (NMPA) announced on October 23, 2023, that Edwards Lifesciences LLC initiated a voluntary Class II recall of several medical devices. This action was reported by Edwards (Shanghai) Medical Supplies Co., Ltd. The recall stems from a potential clogging problem identified in a small number of products within affected batches. The affected products include the Cardiac Volume and Pressure Monitoring Sensor (COP), Disposable Pressure Transducer (two different registration numbers), Acumen IQ Sensor, and another Disposable Pressure Sensor. Each product has a specific National Medical Device Registration Number, indicating their regulatory approval under the NMPA framework. Edwards Lifesciences LLC is taking this voluntary recall action to address the identified potential issue, ensuring patient safety and product reliability. Detailed information regarding the specific models, specifications, and batch numbers subject to recall is available in the "Medical Device Recall Event Report Form" attached to the NMPA's announcement. This proactive measure by the company, under the NMPA's oversight, aims to mitigate any potential risks associated with the reported defect.