China NMPA Product Recall - Urinary guidewire Sensor Guidewire

The National Medical Products Administration (NMPA) reported on March 12, 2020, that Boston Scientific International Medical Trade (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its Urinary Guidewire, specifically the Sensor Guidewire (Registration Certificate No.: 20162094495). This action was taken due to an increase in customer complaints concerning product performance. Affected guidewires reportedly exhibited issues such as difficulty or inability to advance other medical devices along the guidewire, and in some instances, problems withdrawing the guidewire from devices. The manufacturer, Boston Scientific Corporation, proactively identified these quality concerns, leading to the recall. The regulatory framework for this action falls under the NMPA's oversight in China. Required actions include the company's voluntary recall of specific product models, specifications, and batches, with further details provided in an attached "Medical Device Recall Event Report Form." This ensures patient safety by removing non-conforming products from circulation, adhering to medical device vigilance standards.