China NMPA Product Recall - balloon dilation catheter

On July 30, 2021, Cordis (Shanghai) Medical Devices Co., Ltd. announced a voluntary Class II recall for its balloon dilatation catheters. This significant regulatory action, reported under the oversight of the National Medical Products Administration (NMPA), was prompted by the identification of foreign objects discovered inside the device balloons during routine quality inspections by the company's manufacturing facility. Further investigation pinpointed the root cause to contaminated balloon protective sheaths provided by an external supplier. The recall encompasses 35 affected product batches, with 17 batches, comprising 3682 tubes, having been distributed internationally. Cordis effectively managed to quarantine a vast majority of these units3675 tubesin warehouses globally, including 66 units within China, preventing their distribution to patients. Importantly, no affected products were received by end-users in China. A minimal number of devices, specifically seven balloons, reached end-users solely in the United States and other select international countries. Cordis (Shanghai) Medical Devices Co., Ltd. is undertaking this recall to ensure patient safety and product integrity, making detailed product information available in the associated "Medical Device Recall Event Report Form."