# 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/db55f970-3573-4660-876b-c615ff0e9540/
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 April 21, 2016. Recall level: Class I Recall. Talifu Medical Devices Trading (Shanghai) Co., Ltd., acting on behalf of manufacturer Arrow Internat

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Telefel Medical Devices Trading (Shanghai) Co., Ltd. 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: 2016-04-21
- Product Name: Intra-aortic balloon counterpulsation catheter and accessories; Intra-aortic balloon counterpulsation catheter
- Recall Level: Class I Recall
- Recall Reason: During use, the sheath may separate from the sheath connector.
- Discovering Company: Telif Medical Devices Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Arrow International Inc.
- Summary: Talifu Medical Devices Trading (Shanghai) Co., Ltd., acting on behalf of manufacturer Arrow International Inc., initiated a Class I voluntary recall for its Intra-Aortic Balloon Counterpulsation Catheters and accessories. This critical recall, reported to the National Medical Products Administration (NMPA) on February 23, 2016, and published on April 21, 2016, addresses a severe product defect where the catheter's sheath may separate from its connector during clinical use. A Class I classification indicates a high probability of serious adverse health consequences or death. The affected products, essential for cardiac support therapy, are registered under certificate numbers 20153772353 and 20153773791. Globally, 4099 units were impacted by production, with 4028 units sold in China requiring retrieval. The required action involves Teleflex (likely a parent entity) notifying all authorized distributors to facilitate the recall and retrieval of these medical devices. This action highlights the NMPA's commitment to ensuring the safety and quality of medical products in the market.

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