China NMPA Product Recall - Implantable pacing electrode catheters and implantable cardiac pacemakers

The National Medical Products Administration (NMPA) issued a notice on February 22, 2011, regarding a voluntary recall initiated by Boston Scientific International Medical Trading (Shanghai) Co., Ltd., on behalf of its manufacturer, Boston Scientific Corporation, USA. The recall involves specific lots of implantable pacing electrode catheters (model 4457) and implantable cardiac pacemakers (models 1291 and 1294). The primary reason for this recall stems from critical labeling errors on the Chinese product labels. For the implantable pacing electrode catheter, the Chinese label incorrectly displayed the model number as 4480 instead of the correct 4457. Regarding the implantable cardiac pacemaker model 1291 (serial number 156509), an incorrect serial number was present on its Chinese label. Furthermore, for pacemaker model 1294 (serial number 964077), the production and expiration dates were erroneously reversed on the Chinese label. These inaccuracies could lead to product identification issues. Under the regulatory oversight of the NMPA, Boston Scientific voluntarily initiated this recall to address these non-conformances. While the document does not specify inspection dates, it details the company's proactive measure. Provincial regulatory bodies were instructed to acknowledge and monitor the recall process. This action underscores the importance of accurate product information for medical devices distributed in China, ensuring patient safety and regulatory compliance.