China NMPA Product Recall - microguidewire

William Cook Europe ApS, in conjunction with Cook (China) Medical Trading Co., Ltd., initiated a voluntary Class III recall of specific microguidewires following the identification of a significant product specification non-compliance. The recall, reported to the National Medical Products Administration (NMPA) with a publication date of December 12, 2018, concerns microguidewires (Registration Certificate No.: 20173771321) found to be shorter than their stated length. Specifically, model TPMG-14-180-CIR-HC guidewires, from batches E3704223, E3706982, and E3706984, measured only 135cm instead of the intended 180cm. Cook's risk analysis indicated that this discrepancy could prevent the guidewire from reaching its target site during diagnostic and interventional procedures, potentially leading to prolonged procedure times and increased patient risk. The company's required action involves recalling the affected batches from the market. No specific corrective actions were necessary for products not imported into China.