# China NMPA Product Recall - Endoscopic Vessel Harvesting System

Source: https://www.globalkeysolutions.net/records/china_product_recall/maquet-cardiovascular-llc/08256105-789a-4115-a3fb-f6cfb86224ca/
Source feed: China

> China NMPA product recall for Endoscopic Vessel Harvesting System by MAQUET Cardiovascular LLC published April 17, 2025. Recall level: Level 2 Recall. MAQUET Cardiovascular LLC initiated a voluntary Class II recall for its Endoscopic Vessel Harvesting

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: MAQUET Cardiovascular LLC is voluntarily recalling its endoscopic vascular acquisition system.
- Company Name: MAQUET Cardiovascular LLC
- Publication Date: 2025-04-17
- Product Name: Endoscopic Vessel Harvesting System
- Recall Level: Level 2 Recall
- Recall Reason: The ceramic C-ring in this product poses a risk of breakage during use.
- Discovering Company: Maikewei (Shanghai) Medical Equipment Co., Ltd.
- Manufacturing Company: MAQUET Cardiovascular LLC
- Summary: MAQUET Cardiovascular LLC initiated a voluntary Class II recall for its Endoscopic Vessel Harvesting System due to a potential risk of the ceramic C-ring breaking during use. This recall, reported by MAQUET (Shanghai) Medical Equipment Co., Ltd., addresses a critical safety concern regarding the integrity of the medical device. The regulatory oversight for this action falls under the National Medical Products Administration (NMPA) of China, which assigned the recall an index number JGXX-2025-10047, published on April 17, 2025. Although the product holds a National Medical Device Registration Certificate (No. 20173011945), the manufacturer proactively took steps to address the identified defect. Importantly, the specific batches of products implicated in this voluntary recall have not been imported into China. Further detailed information, including product numbers, specifications, and batch identifiers, is available in the official "Medical Device Recall Event Report Form" provided by the company.

Company: https://www.globalkeysolutions.net/companies/maquet-cardiovascular-llc/8fdb5904-f7be-4882-a0c1-a2afca9397eb/