China NMPA Product Recall - Cardiac Ablation System

Boston Scientific Corporation initiated a voluntary recall of its Cardiac Ablation System, as reported by its subsidiary, Boston Scientific International Medical Trading (Shanghai) Co., Ltd. The recall, publicly announced by the National Medical Products Administration (NMPA) on August 27, 2019, addresses a critical product issue. The primary concern involves the potential for unintended continued transmission of radiofrequency energy by the Cardiac Ablation System (Registration No. 20163253093). This malfunction poses a significant safety risk, as it could lead to uncontrolled energy delivery during medical procedures, potentially causing harm to patients. Operating under the oversight of the NMPA, the recall has been designated as Class II, indicating a situation where the product's use may cause temporary or medically reversible adverse health consequences, or where the likelihood of serious health issues is remote. Boston Scientific Corporation is actively taking required actions by voluntarily recalling the affected devices from the market to mitigate potential risks. Further comprehensive information regarding specific affected product models, technical specifications, and relevant batch numbers is detailed in the accompanying "Medical Device Recall Event Report Form." This document serves as the official record providing essential data for stakeholders and healthcare providers regarding the scope and specifics of the recall.