China NMPA Product Recall - SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System

Boston Scientific Corporation initiated a voluntary Class III recall of its SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System, as announced by the National Medical Products Administration (NMPA) on January 5, 2026. This action was prompted by the unauthorized distribution of products manufactured at its Penang, Malaysia facility into the Indian market. India's regulatory framework mandates that only SYNERGY Shield products originating from Boston Scientific's Galway, Ireland site are approved for import and distribution within the country.

The core issues involved a critical inconsistency: the local Indian product labels erroneously stated Galway, Ireland, as the manufacturing location, while the actual factory labels correctly identified Penang, Malaysia. This mislabeling, coupled with the importation of devices from an unapproved manufacturing site into India, constituted a direct violation of Indian national regulations concerning medical device manufacturing site approvals and labeling requirements. Consequently, the affected products failed to meet local regulatory compliance standards.

Boston Scientific Corporation's required action is a voluntary Class III recall to rectify these non-compliance issues. This recall aims to ensure that products not approved for distribution in India are effectively removed from the market, thereby upholding the country's medical device regulations. Comprehensive details regarding the affected product models and specifications are provided in the accompanying Medical Device Recall Event Report Form.