China NMPA Product Recall - Water-circulating microwave ablation needle

Cozy Medical Devices Manufacturing (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its water-circulating microwave ablation needle, with the recall published on May 7, 2019. This action was taken under the oversight of the National Medical Products Administration (NMPA) and documented by the Shanghai Food and Drug Administration (Medical Device Recall 2019-081). The primary safety concern is the potential for the needle tip to detach during medical procedures. Such detachment poses significant risks, including the possibility of leaving foreign body residue within the patient and increasing the risk of infection. To address these issues, Cozy Medical Devices Manufacturing is undertaking two key corrective actions. Firstly, the company is voluntarily recalling affected units of the water-circulating microwave ablation needle (Registration Certificate No.: 20163251456). Secondly, it is revising the product's instruction manual. The updated manual will include enhanced key operating procedures and critical warning information, specifically designed to mitigate the likelihood of needle tip detachment during clinical use. This comprehensive approach aims to improve patient safety and ensure the reliability of the medical device.