# China NMPA Product Recall - Subcutaneous implantable cardioverter defibrillator

Source: https://www.globalkeysolutions.net/records/china_product_recall/boston-scientific-corporation/ab57b3ba-12f1-4830-8df7-de59e263cce4/
Source feed: China

> China NMPA product recall for Subcutaneous implantable cardioverter defibrillator by Boston Scientific Corporation published August 04, 2023. Recall level: Level 2 Recall. Boston Scientific Corporation, through its subsidiary Boston Scientific International Medical Tradin

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Boston Scientific Corporation is voluntarily recalling its subcutaneous implantable cardioverter defibrillators.
- Company Name: Boston Scientific Corporation
- Publication Date: 2023-08-04
- Product Name: Subcutaneous implantable cardioverter defibrillator
- Recall Level: Level 2 Recall
- Recall Reason: Due to a temporary sensing failure
- Discovering Company: Boston Scientific International Medical Trade (Shanghai) Co., Ltd.
- Manufacturing Company: Boston Scientific Corporation
- Summary: Boston Scientific Corporation, through its subsidiary Boston Scientific International Medical Trading (Shanghai) Co., Ltd., initiated a voluntary Class II recall of its subcutaneous implantable cardioverter defibrillator. This action was announced by the National Medical Products Administration (NMPA) on August 4, 2023. The recall addresses an identified issue of temporary sensing failure in the affected medical devices, which are registered under National Medical Device Registration Certificate No. 20153122410. The temporary sensing failure poses a potential risk to patients, prompting the company to undertake this recall to ensure patient safety and product integrity. While specific inspection dates are not detailed in the document, the recall report was publicly released on the aforementioned date. The 'Medical Device Recall Event Report Form' contains comprehensive information regarding the specific models, specifications, and batch numbers of the defibrillators impacted by this recall. As a required action, Boston Scientific is retrieving the affected units from the market. This voluntary recall demonstrates the company's commitment to addressing product performance issues under the oversight of the NMPA, which is responsible for regulating medical devices in China. The NMPA's involvement ensures that medical device manufacturers comply with established standards and take appropriate measures to mitigate risks associated with their products.

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