China NMPA Product Recall - Angioplasty Packs

The National Medical Products Administration (NMPA) announced a voluntary recall initiated by MERIT MEDICAL SYSTEMS, INC. on April 12, 2022. The recall pertains to specific models and batches of Angioplasty Packs for Angioplasty (Registration Certificate No.: 20183662011). The primary issue identified is a design change that has resulted in an internal gap between the rotary valve body and the Y-valve body of the hemostatic valve. This defect may cause difficulty in guidewire advancement during medical procedures, potentially impacting patient safety and treatment efficacy. Merit Medical Devices (Beijing) Co., Ltd., reported this issue, leading to the manufacturer's proactive recall. The document does not specify particular inspection dates related to this incident. The required action by MERIT MEDICAL SYSTEMS, INC. is a voluntary recall to address the product deficiency and ensure compliance with regulatory standards overseen by the NMPA. Further details on affected products are available in an attached recall report form.