# China NMPA Product Recall - Guidewire (product name: Synchro & Synchro2)

Source: https://www.globalkeysolutions.net/records/china_product_recall/boston-scientific-corporation/e62ac3b9-a0ff-4add-bd83-866fe63fe439/
Source feed: China

> China NMPA product recall for Guidewire (product name: Synchro & Synchro2) by Boston Scientific Corporation published July 21, 2010. Recall level: . Boston Scientific, Inc., along with its Chinese affiliate, Boston Scientific International Medical T

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Recall Report Form for Guidewire (Trade Name: Synchro & Synchro2)
- Company Name: Boston Scientific Corporation
- Publication Date: 2010-07-21
- Product Name: Guidewire (product name: Synchro & Synchro2)
- Recall Reason: Through our internal inspection process, we discovered a potential issue with the PTFE coating of affected batches of Synchro nerve wires that could impact patient safety. Specifically, during the manufacturing process of the affected batches, fragments of the PTFE coating may have detached from the center of the wire, potentially becoming free-floating particles. The most foreseeable harm caused by these particles is ischemic stroke; the largest particles we detected were 4200 micrometers in size, which could cause ischemic stroke if they were to enter the cerebral circulation. The areas of risk vary depending on the vascular access and the region where the wire is used.
- Discovering Company: Boston Scientific
- Manufacturing Company: Boston Scientific Corporation
- Summary: Boston Scientific, Inc., along with its Chinese affiliate, Boston Scientific International Medical Trade (Shanghai) Co., Ltd., initiated a recall for their Synchro and Synchro2 guidewires. This action followed an internal inspection that identified a manufacturing defect where polytetrafluoroethylene (PTFE) coating fragments could detach from the guidewires. These free-floating particles, potentially up to 4200 micrometers, pose a risk of ischemic stroke if they enter the cerebral circulation. Although no related complaints or adverse event reports had been received, the recall was a proactive measure to ensure patient safety across affected regions, including China.

The recall was conducted under the regulatory framework of China's National Medical Products Administration (NMPA), as documented in a Medical Device Recall Event Report Form. Required actions included identifying all affected customers based on shipping history, disseminating official notifications via mail, fax, and direct visits, and arranging for the return of the non-conforming products. Boston Scientific set an anticipated completion date for these corrective actions as September 5, 2010.

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