China NMPA Product Recall - Artificial corpus cavernosum and accessories

On September 25, 2020, Boston Scientific International Medical Trading (Shanghai) Co., Ltd. announced a voluntary Class II recall concerning its artificial cavernous body and accompanying accessories. This significant action, publicly disseminated by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration, was initiated to address a critical 'first activation' issue found in specific serial numbers of the product. The affected medical devices are identified under Registration Certificate No. "国械注进20153464206". The company ’s decision to execute this recall demonstrates its commitment to patient safety and adherence to regulatory obligations. A Class II recall, as designated by regulatory bodies, signifies that the use of or exposure to the recalled product may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. This classification indicates a moderate risk level requiring prompt corrective action. Boston Scientific has provided comprehensive details regarding the specific models, specifications, and batches of the impacted products within the 'Medical Device Recall Event Report Form' to facilitate the recall process. This proactive measure ensures that potentially faulty products are removed from circulation, upholding public health standards under the oversight of China's medical product regulatory framework.