China NMPA Product Recall - guiding catheter

Medtronic Inc. initiated a Class II voluntary recall of specific batches of its 6F Taiga guiding catheters, as reported by Medtronic (Shanghai) Management Co., Ltd. to the National Medical Products Administration (NMPA) in October 2017. The recall stems from eight reports received by September 19, 2017, detailing potential tip detachment or cracking of the catheters during in vivo use. These issues could lead to serious patient risks, including unintended medical intervention, stroke, occlusion, embolism, perforation, and dissection, although no related deaths were reported. The affected guiding catheters were manufactured between June 2, 2016, and May 9, 2017. Medtronic identified these batches as subject to the issue. Notably, the corrective action clarifies that while this is a serious recall, the specific affected products were not sold within China, impacting other regions like Japan. This NMPA document serves as the regulatory filing in China for a global corrective action initiated by Medtronic to address the identified product safety concern.