China NMPA Product Recall - Star-shaped magnetoelectric dual-positioning mapping catheter

Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a Class III recall for its Star-shaped Magnetoelectric Dual-positioning Mapping Catheter (PENTARAY®) on July 6, 2016, under the National Medical Products Administration (NMPA) framework. This action followed four customer complaints between January 2014 and March 2016 from global markets, including Canada, China, and Japan, reporting catheter entanglement during surgery in patients with implanted artificial heart valves. Such entanglement could lead to excessive force, causing catheter detachment and potential embolism. While the original product instructions advised that the catheter "may not be suitable" for patients with artificial heart valves, this cautionary language proved insufficient to prevent off-label use. To mitigate future risks, Johnson & Johnson's corrective actions included updating the product's Instructions for Use (IFU) to a stronger, definitive contraindication: "Do not use the PENTARAY® catheter in patients with implanted artificial heart valves." Additionally, affected distributors and hospitals were notified. No product returns were required, and no related complaints or adverse events were reported in China at the time of the recall.