China NMPA Product Recall - guiding catheter

The National Medical Products Administration (NMPA) published a recall notice on October 23, 2014, concerning guiding catheters manufactured by Medtronic, Inc. Medtronic (Shanghai) Management Co., Ltd. officially reported this recall on October 14, 2014. The primary issue involved a significant discrepancy in product labeling: certain guiding catheters (Model LA6JR40K, Lot Number: 0007244836) were incorrectly labeled with an intended usable length of 55 cm, while their actual length was 90 cm. This error was identified through two customer complaints in October 2014, although no patient harm resulted. Operating under the NMPA's regulatory framework for imported medical devices, Medtronic, Inc. initiated the recall, confirming that the affected products were exclusively distributed in the United States and not sold in China. Medtronic has implemented corrective actions to prevent future labeling inaccuracies. Additionally, the NMPA instructed all regional food and drug administrations to enhance their oversight of similar medical devices to safeguard public health.