China NMPA Product Recall - Defibrillation electrode leads (trade name: Riata), Defibrillation electrode leads (trade name: Riata ST)

St. Jude Medical CRMD, through its Chinese entity St. Jude Medical Supplies (Shanghai) Co., Ltd., initiated a voluntary recall of its Riata and Riata ST Defibrillator Leads. This action, overseen by the National Medical Products Administration (NMPA) and reported via the Shanghai Municipal Food and Drug Administration, was prompted by product returns and complaints. The central issue identified was an observed conductor exposure in the silicone leads. Globally, out of 227,000 units sold over nine years, a 0.63% incidence of returns and complaints was recorded, with approximately 15% linked to exposed conductors. As of September 30, 2011, no confirmed serious injuries or deaths directly caused by conductor exposure had been reported. In response, St. Jude Medical delivered a "Doctor's Notice" to implanting physicians, explaining potential problems and guiding identification, correction, and prevention strategies. This notification process began on November 30, 2011, with a planned completion by December 15, 2011. Additionally, provincial food and drug administrations were instructed to enhance supervision of these products.