# China NMPA Product Recall - Thrombectomy stent

Source: https://www.globalkeysolutions.net/records/china_product_recall/stryker-neurovascular/f998209c-bc4e-41ce-b9a0-ab34a12fbc7c/
Source feed: China

> China NMPA product recall for Thrombectomy stent by Stryker Neurovascular published November 23, 2020. Recall level: Level 2 Recall. Stryker Neurovascular, through its affiliate Stryker (Beijing) Medical Devices Co., Ltd., initiated 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Stryker Neurovascular actively recalls thrombectomized stents.
- Company Name: Stryker Neurovascular
- Publication Date: 2020-11-23
- Product Name: Thrombectomy stent
- Recall Level: Level 2 Recall
- Recall Reason: There has been an increase in complaints related to core wire breakage of specific models and batches of thrombectomy stents. This issue can cause the thrombectomy stent to break off from the core wire during use.
- Discovering Company: Stryker (Beijing) Medical Devices Co., Ltd.
- Manufacturing Company: Stryker Neurovascular
- Summary: Stryker Neurovascular, through its affiliate Stryker (Beijing) Medical Devices Co., Ltd., initiated a voluntary Class II recall of its thrombectomy stents. This action, reported to the National Medical Products Administration (NMPA) on November 20, 2020, and published on November 23, 2020, was prompted by an increase in customer complaints regarding core wire breakage within specific models and batches of these critical medical devices. The primary issue identified is the potential for the thrombectomy stent to detach from its core wire during medical procedures. Such an occurrence poses a significant safety concern for patients, as it could compromise the intended therapeutic benefit and potentially lead to adverse events. Under the regulatory oversight of the NMPA, Stryker Neurovascular is recalling devices bearing Registration Certificate No.: 20203030002. The recall specifically targets affected product models, specifications, and batches, with further details provided in a "Medical Device Recall Event Report Form." This voluntary recall underscores the manufacturer's responsibility to address product safety concerns and adhere to regulatory standards for medical devices, prioritizing patient safety.

Company: https://www.globalkeysolutions.net/companies/stryker-neurovascular/dfa4048f-7c78-4970-ab1b-8a34319b33ba/