China NMPA Product Recall - Structural Balloon Trocar and Inflation Bulb

Covidien LLC has initiated a voluntary Class II recall of its Structural Balloon Trocar and Inflation Bulb due to a potential seal failure in the device. This recall, reported by Covidien Medical Devices International Trading (Shanghai) Co., Ltd., was publicly announced by the National Medical Products Administration (NMPA) on April 17, 2024. The issue specifically targets the balloon trocar and inflation bulb, which holds National Medical Device Registration Certificate 20152023828. The company is taking action to address the potential safety concern, with detailed information regarding affected product models, specifications, and batches available in an attached "Medical Device Notice" and "Medical Device Recall Event Report Form." This ensures transparency and provides necessary information for healthcare providers and patients regarding the recalled medical devices.