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

Source: https://www.globalkeysolutions.net/records/china_product_recall/st-jude-medical-crmd/7903fea1-32e1-4f52-bd63-223128c4b3b4/
Source feed: China

> China NMPA product recall for Defibrillation electrode leads (trade name: Riata), Defibrillation electrode leads (trade name: Riata ST) by St. Jude Medical CRMD published January 19, 2012. Recall level: . St. Jude Medical CRMD, through its Chinese entity St. Jude Medical Supplies (Shanghai) Co., Ltd., in

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: St. Jude Medical CRMD is recalling defibrillator leads (brand name: Riata) and defibrillator leads (brand name: Riata ST).
- Company Name: St. Jude Medical CRMD
- Publication Date: 2012-01-19
- Product Name: Defibrillation electrode leads (trade name: Riata), Defibrillation electrode leads (trade name: Riata ST)
- Recall Reason: St. Jude Medical found that among 227,000 Riata and Riata ST silicone wires sold worldwide over the past nine years, the rate of returns and complaints (from regions where products were not returned) is currently 0.63%, compared to 0.47% in December 2010 (see attached for reference only). Approximately 15% of these cases involved exposed conductors.
- Discovering Company: St. Jude Medical Supplies (Shanghai) Co., Ltd.
- Manufacturing Company: St. Jude Medical CRMD
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/st-jude-medical-crmd/7326e75f-0c82-4dd6-900f-b1f52a1f06c9/