China NMPA Product Recall - Guide wire (trade name: Jagwire)

Boston Scientific International Medical Trading (Shanghai) Co., Ltd. initiated a renewed voluntary recall of its Jagwire guidewires, as announced by the National Medical Products Administration (NMPA) on December 29, 2016. This latest action follows two prior recalls in December 2015 and May 2016. The primary issue identified was the detachment of guidewire tips. Investigations concluded that the company's practice of adding plastic protective bags to product packaging, coupled with high-humidity transport and storage conditions, trapped moisture and increased the likelihood of tip detachment. The decision for a renewed recall on November 29, 2016, stemmed from the discovery in November 2016 that a distributor had failed to return all affected guidewires from earlier recall batches. This incomplete product return prompted Boston Scientific to conduct a comprehensive re-examination of all primary distributors and platforms to ensure full retrieval of affected products. Operating under NMPA regulations, the company is responsible for the free replacement of all recalled Jagwire guidewires in mainland China, demonstrating a commitment to product safety and compliance.