China NMPA Product Recall - Multichannel electrophysiological recorder, rotational atherectomy device

Boston Scientific International Medical Trade (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its multichannel electrophysiology recorders and rotational atherectomy interventional therapy devices. This recall was prompted by the discovery of an incorrect product manufacturing address on the Chinese label of the affected products. The issue was reported by Boston Scientific International Medical Trade (Shanghai) Co., Ltd. and published by the National Medical Products Administration (NMPA) and Shanghai Food and Drug Administration on April 28, 2019. The specific registration certificate numbers for the recalled devices are 20153212513 and 20173237060. This action, governed by the NMPA's regulatory framework, requires the company to remove the non-compliant products from the market to ensure accurate product information for consumers and healthcare providers. The detailed list of models, specifications, and batches is available in the "Medical Device Recall Event Report Form" attachment.