China NMPA Product Recall - Everolimus-eluting coronary stent system (trade name: PROMUS Element)

The National Medical Products Administration (NMPA) reported on September 9, 2011, a voluntary customer notification initiated by Boston Scientific International Medical Trading (Shanghai) Co., Ltd. concerning its everolimus-eluting coronary stent systems, specifically the PROMUS Element series. This action, documented under NMPA Index No. JGXX-2011-10095, addressed a specific issue with certain batches of the medical device. The primary concern arose because three products shipped from Boston Scientific's Australian distribution center between May 30 and May 31, 2011, were found to lack the required Australian instructions for use. The manufacturer confirmed that the affected products met all specifications and did not present an elevated risk of patient injury, with no complaints received regarding product performance, only the missing documentation. Under the regulatory framework governing imported medical devices, identified by registration certificate number CFDA (Imported) No. 20113461566, Boston Scientific implemented a corrective action. This involved a customer notification, where the correct Australian instruction manual was provided. The company explicitly stated that this action did not involve the Chinese market, and no products were required to be returned or physically recalled within China. However, the NMPA requested provincial food and drug administrations to enhance their supervision and management of similar medical devices to ensure continued compliance.