China NMPA Product Recall - Intra-aortic balloon counterpulsation catheter and accessories, intra-aortic balloon counterpulsation catheter

Arrow International, Inc. initiated a voluntary Class III recall on June 9, 2021, for specific models and batches of its Intra-Aortic Balloon Counterpulsation Catheter Kit and Accessories, and Intra-Aortic Balloon Counterpulsation Catheter. The primary reason for this action, reported by Talifu Medical Devices Trading (Shanghai) Co., Ltd., was that these products were distributed and sold in certain regions without possessing the necessary marketing approvals. This oversight falls under the regulatory purview of the National Medical Products Administration (NMPA) in China. The recall impacts products identified by Registration Certificate Nos.: 20153772353, 20153032353, 20153033791, and 20153773791. Affected product details are available in the accompanying "Medical Device Recall Event Report Form." The company's required action is to remove these unapproved devices from the market to ensure compliance with medical device regulations.