China NMPA Product Recall - Aortic perfusion cannulation

Edwards Lifesciences LLC has initiated a voluntary Class I recall of its aortic perfusion catheters, as reported to the National Medical Products Administration (NMPA) on November 1, 2019. The recall stems from a critical safety concern: the potential for the catheter to detach from its connector. This detachment could lead to the rupture of the extracorporeal circulation circuit, resulting in serious blood loss for patients. A Class I recall signifies the highest level of recall, indicating that use of or exposure to the product has a reasonable probability of causing serious adverse health consequences or death. The specific affected products are identified under Registration Certificate No.: 20153664200, with detailed model, specifications, and batch numbers available in the associated "Medical Device Report Form." This action, initiated by Edwards Lifesciences LLC through its subsidiary Edwards (Shanghai) Medical Supplies Co., Ltd., demonstrates a proactive response to ensure patient safety and adherence to NMPA’s stringent medical device regulations. It is important to note that this document is a recall notification, and therefore, specific inspection dates are not applicable.