China NMPA Product Recall - Microcatheter Turnpike catheters

The National Medical Products Administration (NMPA) issued an announcement on January 16, 2023, concerning a voluntary Class III recall by Vascular Solutions LLC for specific models and batches of its Turnpike Catheters. The recall, reported by Tailifu Medical Devices Trading (Shanghai) Co., Ltd., addresses significant compliance issues. The affected products were found to be unregistered in the UK (lacking an IPN) and did not possess the mandatory CE marking, which is essential for market entry in Europe. Although the product holds an NMPA Registration Certificate (No.: 20213030098) in China, the recall highlights non-compliance with international regulatory standards. Vascular Solutions LLC initiated this voluntary action to rectify these regulatory discrepancies. Comprehensive details regarding the affected models, specifications, and batch numbers are documented in the "Medical Device Report Form".