China NMPA Product Recall - Iliofemoral vein stent

Angiomed GmbH & Co. Medizintechnik KG has initiated a voluntary Class II recall of its iliofemoral vein stents, distributed by Bard Medical Technology (Shanghai) Co., Ltd. The recall, publicized on March 14, 2023, under the regulatory framework of the National Medical Products Administration (NMPA), addresses a significant safety concern. The primary issue identified is a problem causing embolism in specific models and batches of the medical device, which could pose serious health risks to patients. The affected products are identifiable by National Medical Device Registration Certificate No. 20213130164. While the document does not specify inspection dates, the company's proactive voluntary recall demonstrates a commitment to patient safety. The required actions involve the immediate retrieval of all impacted iliofemoral vein stents from the market. Comprehensive details regarding the specific models, specifications, and batch numbers subject to this recall are provided in the accompanying "Medical Device Notification Form" and the "Medical Device Recall Event Report Form." This decisive action is crucial to prevent further patient harm and maintain compliance with stringent medical device safety standards enforced by the NMPA, ensuring the integrity of medical products within the market.