China NMPA Product Recall - Disposable hemostatic clip with pusher (Resolution Clip Device)

The National Medical Products Administration (NMPA) announced on April 29, 2021, a voluntary Level III recall initiated by Boston Scientific Corporation. This recall involves their single-use Resolution Clip Device with Push-Active Device (Registration Certificate No. 20163020184). The core issue prompting this action is the discovery of discrepancies within the localized data system for certain models and batches of the product. These data system inconsistencies are the main violation requiring immediate attention. Under the NMPA's regulatory framework, Boston Scientific Corporation is required to remove the affected medical devices from circulation. The company's voluntary recall serves as the primary required action to address the identified product issue. Comprehensive details regarding the specific models, specifications, and batch numbers impacted by this recall are provided in the "Medical Device Recall Event Report Form," which is referenced as an attachment to the NMPA's official notice. This action highlights the importance of data system accuracy in medical device manufacturing and the commitment to patient safety under NMPA's supervision.