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

Source: https://www.globalkeysolutions.net/records/china_product_recall/boston-scientific-corporation/70ad5c3b-a22c-4daa-b19d-63ebb99f5ada/
Source feed: China

> China NMPA product recall for Guide wire (trade name: Jagwire) by Boston Scientific Corporation published December 29, 2016. Recall level: . Boston Scientific International Medical Trading (Shanghai) Co., Ltd. initiated a renewed voluntary r

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Boston Scientific International Medical Trading (Shanghai) Co., Ltd. is again voluntarily recalling guidewires.
- Company Name: Boston Scientific Corporation
- Publication Date: 2016-12-29
- Product Name: Guide wire (trade name: Jagwire)
- Recall Reason: Boston Scientific noted an upward trend in product complaints from China regarding guidewire (trade name: Jagwire) tip detachment in October and November 2015. This increase was attributed to the practice of using plastic protective bags in the outer packaging of products in China. Investigations revealed that moisture generated during transportation and storage in high-humidity environments is trapped inside the plastic bags, increasing the likelihood of tip detachment.
- Discovering Company: Boston Scientific International Medical Trade (Shanghai) Co., Ltd.
- Manufacturing Company: Boston Scientific Corporation
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/boston-scientific-corporation/29488af7-a1d7-4d3b-a8ab-1f12fddb5e4b/