China NMPA Product Recall - Carotid artery stent (monorail type) (trade name: Wallstent), guidewire

Boston Scientific International Medical Trading (Shanghai) Co., Ltd. initiated a Level III voluntary recall for specific batches of its carotid artery stents (Wallstent, monorail type) and associated guidewires. This action, reported to the National Medical Products Administration (NMPA) on October 18, 2018, stemmed from label discrepancies discovered in Brazil. The issue involved variations between the Brazilian localized labels and the original manufacturing labels regarding batch numbers, UPNs, and/or expiration dates. Importantly, the company confirmed that the products themselves adhered to all manufacturing and usage specifications, indicating a labeling error rather than a product performance defect. Due to the affected product batches not being distributed or sold within China, Boston Scientific International Medical Trading (Shanghai) Co., Ltd. stated that no additional recall measures, beyond the initial regulatory report to the NMPA, would be undertaken in the Chinese market. No further investigation or recall plan submissions are required for China.