China NMPA Product Recall - Vascular stent

Terumo Medical Products (Shanghai) Co., Ltd., representing manufacturer Terumo Co., Ltd., initiated a voluntary Class II recall of its Vascular Stents, as documented by the National Medical Products Administration (NMPA) on September 30, 2016. The recall stemmed from internal production and inspection processes, which identified a manufacturing concern: pressure applied during the assembly of the stent and its delivery system could induce slight deformation. This issue potentially leads to incomplete stent expansion, causing a reduction in diameter at the stent's ends or overall deformation. The affected products, encompassing various models and batch numbers (e.g., SX-FXA0640LN, batch 151109), were designed for treating acute occlusion in superficial femoral artery lesions. Importantly, Terumo reported no customer complaints or adverse events worldwide related to this specific issue at the time of the recall. As a corrective measure, the company decided to uniformly recall and destroy all implicated vascular stents. Specifically, products already imported into China but not yet sold were subject to recall and destruction, as no sales had occurred within China for these batches. The company committed to ongoing monitoring for any future customer complaints regarding this product.