China NMPA Product Recall - Angiography catheter

Boston Scientific International Medical Trading (Shanghai) Co., Ltd., representing Boston Scientific Corporation, initiated a voluntary Level II recall for specific batches of angiography catheters. This action was reported by the National Medical Products Administration (NMPA) on January 13, 2017. The primary issue identified was missing bottom seals on the packaging of the angiography catheters (NMPA Registration Certificate No. 20153774215), which was attributed to an error in the packaging process involving alternating label printing. The affected products are intended for delivering contrast agents to selected vascular sites. In response, Boston Scientific is recalling the identified batch, issuing advisory letters to customers detailing affected specifications and batch numbers, and will provide free replacement of all impacted products in the relevant regions. These measures aim to address the packaging defect and maintain product safety standards.