China NMPA Product Recall - Floating Catheters (Thermodilution/Non-Thermodilution)

Edwards Lifesciences LLC, in conjunction with its agent Edwards (Shanghai) Medical Supplies Co., Ltd., initiated a voluntary Level I recall for specific batches of its floating catheters (National Medical Device Registration Certificate 20163774711), including models such as 131F7P. This recall, originally reported on December 21, 2018, was upgraded to Level I on February 19, 2019, under the regulatory oversight of the National Medical Products Administration (NMPA) of China. The core issue stems from incorrect lumen assembly, resulting in reversed lumens within the Swan Ganz catheters. This defect can lead to clinicians observing inaccurate pulmonary artery (PA) and central venous pressure (CVP) values and waveforms. Should these reversed readings go unnoticed, there is a potential for unintended or inappropriate patient treatment due to misleading diagnostic information. Despite this, no patient complications have been reported to date. As required actions, Edwards Lifesciences LLC is notifying all affected customers globally and ensuring all unused products from the identified affected batches, specifically 61176369 and 61321241 (totaling 600 units imported to China), are returned and will be locally destroyed.