# China NMPA Product Recall - Implantable Left Ventricular Assist System

Source: https://www.globalkeysolutions.net/records/china_product_recall/abbott-medical-devices/6944e9ce-4861-4f74-bf0b-a9f6e20c432c/
Source feed: China

> China NMPA product recall for Implantable Left Ventricular Assist System by Abbott Medical Devices published October 29, 2025. Recall level: Level 1 Recall. Abbott Medical Products (Shanghai) Co., Ltd., on October 29, 2025, initiated a voluntary Class I rec

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Abbott Medical is issuing a voluntary recall for its implantable Left Ventricular Assist System.
- Company Name: Abbott Medical Devices
- Publication Date: 2025-10-29
- Product Name: Implantable Left Ventricular Assist System
- Recall Level: Level 1 Recall
- Recall Reason: The issue concerns a potential problem where excessive handling of the ribbon cable connection interface could trigger a backup battery alarm on the system controller.
- Discovering Company: Abbott Medical (Shanghai) Co., Ltd.
- Manufacturing Company: Abbott Medical Devices
- Summary: Abbott Medical Products (Shanghai) Co., Ltd., on October 29, 2025, initiated a voluntary Class I recall of its Implantable Left Ventricular Assist System (National Medical Device Registration Certificate No. 20243120384). This recall, overseen by the National Medical Products Administration (NMPA), addresses a critical product issue. The primary concern is that excessive handling of the ribbon cable connection interface can potentially trigger a backup battery alarm within the system controller. This defect poses a significant risk, leading to the highest level of recall to ensure patient safety. Abbott Medical Products is proactively taking steps to address this manufacturing concern, with detailed information regarding the affected product models, specifications, and batch numbers available in the attached Medical Device Recall Event Report Form. The company's immediate action underscores its commitment to regulatory compliance and patient well-being, necessitating the prompt removal of affected devices from the market to mitigate potential adverse events.

Company: https://www.globalkeysolutions.net/companies/abbott-medical-devices/febfa01e-9e15-4f25-8627-6d8bd96868aa/