China NMPA Product Recall - Nickel-titanium support system (trade name: PRECISE)

Contis (Shanghai) Medical Devices Co., Ltd., representing manufacturer Cordis Corporation, initiated a voluntary Class II recall for its PRECISE Nickel-Titanium Stent Systems. The recall was reported on May 12, 2016, and publicly announced by the National Medical Products Administration (NMPA) on July 6, 2016. The primary issue prompting this global recall stems from an increasing trend of product release difficulties during use. Specifically, the stent systems experienced failure to release or release difficulties, sometimes accompanied by the breakage of the release rod sleeve. These devices are critical for treating carotid atherosclerosis. Under the regulatory oversight of the NMPA, the company decided to recall 179 batches across 16 different part numbers of the affected stent systems. A total of 1,742 units were imported into China, with 1,151 units sold within the country. As a required action, Contis (Shanghai) Medical Devices Co., Ltd. notified all affected distributors and customers to retrieve any unused products to ensure patient safety and compliance with medical device regulations.