China NMPA Product Recall - Angiography catheter (5F curved tip angiography catheter)

Boston Scientific International Medical Trading (Shanghai) Co., Ltd. issued an updated voluntary recall on August 11, 2020, for its 5F curved tip angiography catheters. This action revises an earlier recall initiated on February 13, 2020. The company received notification from its headquarters that additional product batches globally might exhibit similar issues to those previously identified, which were not encompassed in the initial recall. Under the oversight of the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration, this recall is classified as Class I, indicating a situation where there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. Boston Scientific International Medical Trading (Shanghai) Co., Ltd. is voluntarily recalling all products under Registration Certificate No.: 20153774215. The detailed models, specifications, and affected batch numbers are provided in an accompanying Medical Device Recall Event Report Form. This updated recall underscores the company's commitment to product safety and compliance with regulatory requirements.