China NMPA Product Recall - Maestro 4000 Cardiac Ablation System

On January 15, 2020, the National Medical Products Administration (NMPA) announced a voluntary Class II recall initiated by Boston Scientific International Medical Trade (Shanghai) Co., Ltd. This action concerns their Maestro 4000 Cardiac Ablation System (Registration Certificate No.: 20163253093). The company received reports indicating that the device unexpectedly continued to deliver radiofrequency energy even after the foot switch was released.

Boston Scientific, however, stated that the Maestro 4000 is performing as expected and that this rare occurrence can be addressed by following existing instructions within the product's user manual. Crucially, the company reported no complaints or adverse patient events in China related to this specific issue.

The recall, deemed voluntary, aims to address the reported operational discrepancy, even if user manual instructions can mitigate it. Detailed information regarding the specific models, specifications, and batches of affected products is available in the associated 'Medical Device Recall Event Report Form.' This regulatory announcement underscores the NMPA's oversight in ensuring medical device safety and the responsibility of manufacturers in addressing product performance concerns.