China NMPA Product Recall - Electrophysiological navigation system (trade name: CARTO 3)

Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., under the oversight of the National Medical Products Administration (NMPA), initiated a voluntary Class II recall for its Electrophysiological Navigation System, known as CARTO 3. This action was officially published by the NMPA on December 7, 2016, following the company's internal report dated September 8, 2016. The recall encompassed 54 units of the CARTO 3 system in China. The primary concern arose from the improper transfer of these systems between hospitals by clinical specialists. Crucially, required retesting by Biosense Webster technical service personnel, as stipulated in the product's Instructions for Use, was not performed before subsequent clinical applications. This non-compliance posed a risk of system operational problems, including inaccurate magnetic positioning and potential surgical delays, with a hypothetical risk of serious malfunction. No adverse events had been reported directly linked to this issue at the time of the recall. Johnson & Johnson implemented corrective measures by notifying all affected customers and deploying technical service personnel to conduct comprehensive retesting on every affected machine, ensuring correct system functionality and obtaining relevant technical service reports.