# China NMPA Product Recall - Intra-aortic balloon counterpulsation pump

Source: https://www.globalkeysolutions.net/records/china_product_recall/arrow-international-inc/a764aa1c-b5fb-4611-9360-844f621fb0ee/
Source feed: China

> China NMPA product recall for Intra-aortic balloon counterpulsation pump by Arrow International Inc. published December 21, 2022. Recall level: Level 1 Recall. The National Medical Products Administration (NMPA) has announced a significant recall concerning In

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Arrow International LLC Changes Recall Level for Intra-Aortic Balloon Pulse Pump Products
- Company Name: Arrow International Inc.
- Publication Date: 2022-12-21
- Product Name: Intra-aortic balloon counterpulsation pump
- Recall Level: Level 1 Recall
- Recall Reason: The product may experience issues such as battery power failure.
- Discovering Company: Telif Medical Devices Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Arrow International Inc.
- Summary: The National Medical Products Administration (NMPA) has announced a significant recall concerning Intra-Aortic Balloon Counterpulsation Pumps manufactured by Arrow International LLC. This recall, initially reported by Telefel Medical Devices Trading (Shanghai) Co., Ltd., was officially published on December 21, 2022. The primary reason for the recall stems from potential battery power failures and other unspecified issues that could compromise the safety and effectiveness of these critical medical devices. Initially classified as a level two recall, the severity has been escalated to level one. This change signifies a heightened risk to patient health, prompting more urgent and extensive action by the manufacturer and distributors. Arrow International LLC is voluntarily recalling specific models of these pumps, identified by registration certificate numbers such as 20203080452, 20153081603, 20153211603, and 20113211652. Detailed product information, including models, specifications, and batch numbers, is available in the associated 'Medical Device Recall Event Report Form.' This action is taken under the NMPA's regulatory oversight to ensure the safety and reliability of medical products in the market.

Company: https://www.globalkeysolutions.net/companies/arrow-international-inc/8820e141-5ce7-4e2d-844a-672ff4232c9c/