# China NMPA Product Recall - Intra-aortic balloon counterpulsation catheter and accessories, intra-aortic balloon counterpulsation catheter

Source: https://www.globalkeysolutions.net/records/china_product_recall/arrow-international-inc/8683e655-4708-4275-8c4e-2a48334552ab/
Source feed: China

> China NMPA product recall for Intra-aortic balloon counterpulsation catheter and accessories, intra-aortic balloon counterpulsation catheter by Arrow International Inc. published June 09, 2021. Recall level: Level 3 Recall. Arrow International, Inc. initiated a voluntary Class III recall on June 9, 2021, for specific model

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Arrow International, Inc. is voluntarily recalling intra-aortic balloon counterpulsation catheters and accessories, as well as intra-aortic balloon counterpulsation catheters.
- Company Name: Arrow International Inc.
- Publication Date: 2021-06-09
- Product Name: Intra-aortic balloon counterpulsation catheter and accessories, intra-aortic balloon counterpulsation catheter
- Recall Level: Level 3 Recall
- Recall Reason: Certain models and batches of products were sold in the relevant regions despite not having obtained market approval there.
- Discovering Company: Telif Medical Devices Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Arrow International Inc.
- Summary: Arrow International, Inc. initiated a voluntary Class III recall on June 9, 2021, for specific models and batches of its Intra-Aortic Balloon Counterpulsation Catheter Kit and Accessories, and Intra-Aortic Balloon Counterpulsation Catheter. The primary reason for this action, reported by Talifu Medical Devices Trading (Shanghai) Co., Ltd., was that these products were distributed and sold in certain regions without possessing the necessary marketing approvals. This oversight falls under the regulatory purview of the National Medical Products Administration (NMPA) in China. The recall impacts products identified by Registration Certificate Nos.: 20153772353, 20153032353, 20153033791, and 20153773791. Affected product details are available in the accompanying "Medical Device Recall Event Report Form." The company's required action is to remove these unapproved devices from the market to ensure compliance with medical device regulations.

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