China NMPA Product Recall - Disposable star-shaped mapping catheter with TRUEref Technology (National Medical Device Registration Certificate No. 20233070056)

Biosense Webster, Inc., a subsidiary of Johnson & Johnson, has initiated a voluntary Class III recall of its OCTARAY Mapping Catheter with TRUEref Technology (NMPA Registration Certificate No. 20233070056). This action, announced by the National Medical Products Administration (NMPA) on June 14, 2023, follows overseas reports of blood eschar adhering to the electrodes and branches of the single-use star-shaped mapping catheter when it is utilized with an ablation catheter. This observation raises concerns about the device's functionality and potential patient safety implications during clinical procedures.

The recall is being managed by Biosense Webster, Inc., with distribution facilitated by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. The NMPA, as the governing regulatory authority, has categorized this as a Class III recall, signifying that the use of or exposure to the affected product is not likely to result in adverse health consequences. Detailed information, including specific models, specifications, and batch numbers of the implicated catheters, is available in the accompanying "Medical Device Recall Event Report Form." Healthcare providers and relevant entities are advised to consult this document for precise identification of affected units and to implement the necessary recall protocols to uphold patient safety and regulatory compliance.