China NMPA Product Recall - Releaseable coil (Product name: Target)

Stryker Neurovascular, through Stryker (Beijing) Medical Devices Co., Ltd., initiated a Class III voluntary recall of specific batches of its Target Nano releasable coils. This action was reported to the National Medical Products Administration (NMPA) on June 17, 2016, and publicly announced on July 15, 2016. The recall, which impacts regions including China, the EU, Japan, and the USA, addresses a critical product malfunction. The main issue identified was the breakage of the anti-unwinding wire within certain Target Nano releasable coils. This defect occurred during routine electrical positioning testing in the manufacturing process. Equipment failure led to the coils being exposed to temperatures exceeding the anti-unwinding wire's melting point, causing the wire to melt and break, which in turn allowed the coil to stretch and unwind. The affected product is registered under CFDA (Imported) No. 20133773913. As a corrective action, Stryker Neurovascular is requiring all affected products to be returned for centralized processing to ensure their removal from the market.