China NMPA Product Recall - microguidewire

William Cook Europe ApS, with its agent Cook (China) Medical Trading Co., Ltd., initiated a voluntary Class III medical device recall of specific microguidewire batches (Lot# E3704223, E3706982, E3706984, model TPMG-14-180-CIR-HC). This recall, reported to the National Medical Products Administration (NMPA) and dated December 13, 2018 (with the recall report dated June 29, 2018), was prompted by a significant product non-compliance issue. Investigation revealed that the microguidewires were notably shorter than their stated length, measuring 135cm instead of the intended 180cm. Cook's risk analysis identified that this discrepancy could prevent the device from reaching the target site during diagnostic and interventional procedures, potentially prolonging procedure times. The regulatory framework for this action falls under the NMPA's medical device oversight. In response, Cook Europe is voluntarily recalling the affected product batches. No further corrective actions or specific measures were required in China beyond the recall of the already imported affected products, as the issue was addressed at the manufacturer level.