China NMPA Product Recall - Saline infusion microelectrode ablation catheter

The National Medical Products Administration (NMPA) published a notice concerning Boston Scientific Corporation's voluntary Class III recall of its Saline Irrigation Microelectrode Ablation Catheter. Initiated by Boston Scientific International Medical Trading (Shanghai) Co., Ltd., this recall addresses a minor, unfiled change in the material composition—specifically, pigment variations—of a cooling lumen assembly within certain catheter batches. This alteration was not reflected in Boston Scientific's regulatory submissions in Japan. Boston Scientific, the manufacturer, confirmed that this material modification poses no foreseeable risk to patient safety and does not compromise product performance, adhering to all quality standards. The recall is exclusively limited to Japan, with no affected units (models M004PM96200, M004PM9620K20, M004PM9620N40) having been sold or imported into China. Under the NMPA's regulatory framework, Boston Scientific International Medical Trading (Shanghai) Co., Ltd. will only report this event to the NMPA. No further recall measures, investigations, or plans will be executed in China, given the domestic market remains unaffected. The NMPA notice was published on December 12, 2018, following Boston Scientific China's report on December 5, 2018.