China NMPA Product Recall - Ureteral stent

Bard Medical Technology (Shanghai) Co., Ltd., representing manufacturer C.R. Bard, Inc., initiated a voluntary Class II recall for its InLay Optima and InLay Ureteral Stents. The recall, reported on October 25, 2016, and published by the National Medical Products Administration (NMPA) on December 7, 2016, addresses a significant safety issue: the potential for these ureteral stents to form knots. This knotting can lead to increased resistance during stent removal, posing a risk of ureter injury and potentially requiring additional surgical intervention for patients. The regulatory framework for this action involves both the NMPA in China and the U.S. Food and Drug Administration (FDA), which had previously requested similar labeling changes from manufacturers. As required actions, Bard Medical Technology agreed to update the product labeling for all multi-length ureteral stents. The revised 'Warnings/Precautions' section now explicitly cautions users about potential knot formation, the associated risks of injury and additional surgery, and advises considering a knot's presence if significant resistance is met during removal. Additionally, customer notification letters are being distributed to ensure healthcare providers are fully informed of this crucial safety update.