# China NMPA Product Recall - Intra-aortic occlusion catheter

Source: https://www.globalkeysolutions.net/records/china_product_recall/edwards-shanghai-medical-supplies-co-ltd/c13938a9-5076-4a3a-93f0-ea005b7d28a3/
Source feed: China

> China NMPA product recall for Intra-aortic occlusion catheter by Edwards (Shanghai) Medical Supplies Co., Ltd. published January 22, 2019. Recall level: Level 2 Recall. Edwards (Shanghai) Medical Supplies Co., Ltd. has initiated a voluntary Class II recall of its intra

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Edwards (Shanghai) Medical Supplies Co., Ltd. has initiated a voluntary recall of its intra-aortic occlusion catheter.
- Company Name: Edwards (Shanghai) Medical Supplies Co., Ltd.
- Publication Date: 2019-01-22
- Product Name: Intra-aortic occlusion catheter
- Recall Level: Level 2 Recall
- Recall Reason: The product in question suffers from problems such as leakage of the cardioplegic solution between the aortic root perfusion chamber and the pressure chamber, resulting in the inability to continuously deliver the cardioplegic solution to the heart.
- Discovering Company: Edwards (Shanghai) Medical Supplies Co., Ltd.
- Manufacturing Company: Edwards (Shanghai) Medical Supplies Co., Ltd.
- Summary: Edwards (Shanghai) Medical Supplies Co., Ltd. has initiated a voluntary Class II recall of its intra-aortic occlusion catheter, as reported on January 22, 2019. This action was taken due to a critical design flaw identified in the product: leakage of cardiac arrest fluid between the perfusion chamber and pressure chamber of the aortic root. This defect compromises the catheter's ability to continuously deliver cardiac arrest fluid to the heart, posing a significant risk to patient safety. The recall, detailed under Shanghai Food and Drug Administration Medical Device Registration Certificate No.: 2019-003 and product Registration Certificate No.: 20183132601, is overseen by the National Medical Products Administration (NMPA). The company is providing a "Medical Device Recall Event Report Form" with specific information on affected models, specifications, and batch numbers. The recall highlights the importance of medical device vigilance and the regulatory framework's role in ensuring product safety within China.

Company: https://www.globalkeysolutions.net/companies/edwards-shanghai-medical-supplies-co-ltd/6cb13327-9284-43be-afa3-e467e6c339e2/