# China NMPA Product Recall - Aortic perfusion cannulation

Source: https://www.globalkeysolutions.net/records/china_product_recall/edwards-lifesciences-llc/cea50bab-b938-49db-ac7a-d4b0fbdd17bd/
Source feed: China

> China NMPA product recall for Aortic perfusion cannulation by Edwards Lifesciences LLC published November 04, 2019. Recall level: Level 1 Recall. The National Medical Products Administration (NMPA) announced a Class I voluntary recall initiated b

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Edwards Lifesciences LLC is voluntarily recalling aortic perfusion cannulas.
- Company Name: Edwards Lifesciences LLC
- Publication Date: 2019-11-04
- Product Name: Aortic perfusion cannulation
- Recall Level: Level 1 Recall
- Recall Reason: The cannula may detach from the connector, leading to a rupture of the extracorporeal circulation circuit and blood loss.
- Discovering Company: Edwards (Shanghai) Medical Supplies Co., Ltd.
- Manufacturing Company: Edwards Lifesciences LLC
- Summary: The National Medical Products Administration (NMPA) announced a Class I voluntary recall initiated by Edwards Lifesciences LLC for its aortic perfusion catheters. The recall was reported on November 4, 2019, by Edwards (Shanghai) Medical Supplies Co., Ltd. This urgent action stems from a critical potential safety concern: the catheter may detach from its connector, which could lead to the rupture of the extracorporeal circulation circuit and significant patient blood loss. The Registration Certificate No. for the affected devices is 20153664200. Edwards Lifesciences LLC, as the manufacturer, is taking responsibility for this recall due to the serious health risks associated with the product defect. A Class I recall designation by the NMPA signifies that there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. While specific inspection dates are not provided in this notice, the recall itself serves as a critical regulatory action taken in response to an identified product flaw posing substantial patient risk. The required action from the company is to execute a voluntary recall, with comprehensive details regarding the specific affected product models, specifications, and batch numbers available in the "Edwards Lifesciences Event Report Form". This ensures that healthcare providers and facilities can accurately identify and remove the faulty devices from circulation, safeguarding patient safety and complying with NMPA's regulatory mandates. This proactive measure aims to mitigate the severe risks associated with the product malfunction.

Company: https://www.globalkeysolutions.net/companies/edwards-lifesciences-llc/d78876e8-6a4a-49b4-8cb5-30579a7ed097/