China NMPA Product Recall - Ureteral stents (InLay Optima Uretera Stent, InLay Ureteral Stents)

Bard Medical Technology (Shanghai) Co., Ltd., on behalf of manufacturer C.R. Berd, Inc., initiated a voluntary Class II recall of specific ureteral stent models. This recall, reported by the company on October 25, 2016, and publicly announced by the National Medical Products Administration (NMPA) on February 6, 2017, addresses a significant safety concern. The main issue identified is the potential for these ureteral stents to form knots. This knotting can cause considerable resistance during stent removal, potentially leading to injury of the ureter and the need for additional surgical intervention for patients. In response, and in alignment with regulatory requirements from both the NMPA and the U.S. Food and Drug Administration (FDA), Bard is undertaking critical corrective actions. The company has agreed to revise the product labeling for all affected multi-length ureteral stents. The updated labeling will include a clear warning and precaution statement, advising healthcare professionals to consider the presence of a knot if notable resistance is encountered during removal. Bard also committed to issuing customer notifications to ensure users are promptly informed of these vital safety updates.