China NMPA Product Recall - Amplatz Super Stiff™ guidewire

Boston Scientific Corporation has initiated a voluntary Class III recall for certain batches of its Amplatz Super Stiff ™ guidewires, as reported to China's National Medical Products Administration (NMPA) on September 29, 2025. This recall specifically targets products exported to China due to critical labeling inconsistencies. The primary issue identified is that the product labels display incorrect information regarding the tapered interval length, total length, and diameter. These measurements are either inconsistent with other details on the same label or do not accurately reflect the actual product dimensions inside the packaging. Such discrepancies are significant as they could potentially impact product selection or usage. Operating under the regulatory framework of the NMPA, Boston Scientific Corporation is undertaking this voluntary action to rectify these labeling errors and uphold product accuracy and patient safety standards. Detailed information concerning the specific models, specifications, and batch numbers affected by this recall is available in the associated "Medical Device Recall Event Report Form," which serves as the official documentation for this event. This proactive measure by Boston Scientific underscores their commitment to addressing product information variances.