China NMPA Product Recall - Water-circulating microwave ablation needle

Cozy Medical Devices Manufacturing (Shanghai) Co., Ltd. has initiated a voluntary Class II recall of its water-circulating microwave ablation needle. This action, publicly reported by the National Medical Products Administration (NMPA) on April 26, 2019, stems from a critical safety concern: the potential for intraoperative needle tip detachment. Such an event could lead to foreign body residue within a patient, consequently increasing the risk of infection. The company identified this issue, prompting a proactive response to safeguard patient well-being. To address the root cause, Cozy Medical Devices Manufacturing is updating the product's instruction manual. The revised manual will incorporate enhanced key operating procedures and vital warning information specifically designed to minimize the likelihood of needle tip detachment during surgical operations. The recall encompasses specific product models, specifications, and batches, details of which are outlined in the accompanying "Medical Device Recall Event Report Form." This voluntary recall demonstrates the company's commitment to product safety under the oversight of regulatory bodies such as the NMPA, ensuring compliance with medical device registration requirements and prioritizing patient safety in the use of their devices.