China NMPA Product Recall - septal puncture needle

Cook Incorporated, through its agent Cook (China) Medical Trading Co., Ltd., initiated a Class II voluntary recall of specific atrial septal puncture needles (Model: TSNC-18-71.0, Lot: 8833687). The National Medical Products Administration (NMPA) published this recall on February 19, 2019, following the company's report on January 30, 2019. The recall stems from a critical manufacturing defect where the needle tip lacked a bevel. This flaw poses a significant risk during cardiac interventional procedures, as it could damage the internal components of the insertion sheath, potentially compromising patient safety and procedural efficacy. The affected product, registered under NMPA Certificate No. 20143155640, is designed for use by specialized physicians to establish left ventricular access. Cook discovered the defect during a customer complaint analysis, identifying 100 affected units already distributed in the United States and Canadian markets. The required action involves the voluntary removal of these defective devices from circulation to mitigate potential risks associated with their use. The report emphasizes the product's intended use by trained professionals, adhering to standard operating procedures.