China NMPA Product Recall - Saline infusion microelectrode ablation catheter

Boston Scientific Corporation voluntarily initiated a Class III recall for its Saline Irrigation Microelectrode Ablation Catheter (IntellaTip MiFi Open-Irrigated Ablation Catheter) as reported to China's National Medical Products Administration (NMPA) on December 13, 2018, with the recall report dated December 5, 2018. The recall stems from a minor change in the material composition of a cooling lumen assembly, specifically pigment variations, which were not reflected in the company's regulatory filings in Japan, where the recall originated. Although a material change occurred, Boston Scientific determined that this alteration does not pose a foreseeable risk to patient safety, nor does it affect product performance, with the product still meeting all quality specifications. The regulatory framework involved the submission of a Medical Device Recall Event Report Form to the NMPA. Crucially, the affected product batches were sold exclusively in Japan, meaning no units were distributed in China. Consequently, Boston Scientific International Medical Trade (Shanghai) Co., Ltd. is not required to take further recall actions within China beyond the initial NMPA reporting, and will not submit additional investigative reports or recall plans in the region.