China NMPA Product Recall - Disposable magnetically positioned cardiac pulsed electric field ablation catheter, Varipulse Bi-directional Catheter

On March 27, 2025, Biosense Webster (Israel) Ltd., the manufacturer, in collaboration with Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., its reporting entity, announced a voluntary recall of its single-use magnetic-directed cardiac pulsed electric field ablation catheter, specifically the Varipulse Bi-directional Catheter. This significant action was initiated due to observed data indicating a higher-than-expected rate of perioperative strokes among patients utilizing the device. The recall is classified as Class I, a designation reserved for situations where there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. This serious regulatory measure affects products distributed within mainland China, specifically those registered under National Medical Device Registration Certificate No. 20253010070. The oversight and reporting framework for this event are managed by the National Medical Products Administration (NMPA) of China. The required action involves the voluntary removal of all affected batches of the Varipulse Bi-directional Catheter from the market. Further comprehensive information detailing the specific models, specifications, and batch numbers implicated in this recall is available in the 'Medical Device Recall Event Report Form' provided by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. This proactive measure aims to mitigate potential patient risks associated with the device's use.