China NMPA Product Recall - Angiographic Catheter

Boston Scientific Corporation initiated a voluntary Class I recall of its Angiographic Catheter product, as reported by the National Medical Products Administration (NMPA) on August 17, 2020. The recall was prompted by customer complaints indicating that the tip of certain product batches could become brittle due to external factors. This brittleness poses a significant risk, as it may lead to the detachment of the catheter tip either during surgical procedures or prior to use. The potential for tip detachment could result in serious adverse health consequences for patients, warranting the highest level of recall. Boston Scientific International Medical Trade (Shanghai) Co., Ltd. communicated this serious product defect, leading to the manufacturer's decision to remove the affected devices from the market. The specific details regarding the recalled product's registration certificate, model, specifications, and batch numbers are available in the accompanying "Medical Device Recall Event Report Form." This action underscores the company's commitment to patient safety and adherence to NMPA regulations concerning medical device quality and performance.