China NMPA Product Recall - guide wire

The National Medical Products Administration (NMPA) issued notice JGXX-2017-10487 on June 19, 2017, detailing a voluntary Class II recall by Boston Scientific International Medical Trading (Shanghai) Co., Ltd. This action was initiated because the company reported an incomplete previous recall of its guidewires, registered under CFDA (Imported) No. 201237733. The core issue centers on ensuring the comprehensive withdrawal of all affected medical devices from circulation after an initial recall effort was found to be insufficient. While the specific reasons for the original recall and the precise nature of the incompleteness are not elaborated in this public announcement, the company is taking corrective measures to fulfill its obligations. This Class II recall indicates that the product may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. Boston Scientific International Medical Trading (Shanghai) Co., Ltd. is undertaking this renewed recall to rectify the identified gap, demonstrating its commitment to robust post-market surveillance and regulatory adherence under the NMPA's framework. Detailed information regarding the specific affected product models, specifications, and batch numbers is available in the "Medical Device Recall Event Report Form" associated with the NMPA's official publication. This event highlights the critical importance of effective and complete recall procedures in the medical device industry to safeguard public health.