# China NMPA Product Recall - Extracorporeal Blood Pumping Console

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-inc/a311c5ca-7c20-420d-a3b2-b5c3015289a3/
Source feed: China

> China NMPA product recall for Extracorporeal Blood Pumping Console by Medtronic Inc. published March 25, 2022. Recall level: Level 1. On March 25, 2022, Medtronic Inc., through its subsidiary Medtronic (Shanghai) Management Co., Ltd.,

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic Inc. is proactively recalling its Extracorporeal Blood Pumping Console.
- Company Name: Medtronic Inc.
- Publication Date: 2022-03-25
- Product Name: Extracorporeal Blood Pumping Console
- Recall Level: Level 1
- Recall Reason: The difference in maximum input voltage between the spare component and the original component causes voltage deviations in the host system controller module. Transient voltage spikes in the system controller module can lead to problems with the DC-DC converter and D88 diode.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic Inc.
- Summary: On March 25, 2022, Medtronic Inc., through its subsidiary Medtronic (Shanghai) Management Co., Ltd., initiated a voluntary Class I recall of its Extracorporeal Blood Pumping Console Centrifugal Pump Control Monitoring System. This recall was reported to the National Medical Products Administration (NMPA) in China. The primary issue identified involves a critical design difference: a spare component possesses a maximum voltage input that differs from the original component. This discrepancy can lead to voltage spikes within the main unit's system controller module, potentially causing failures in the DC-DC converter and D88 diode. Such failures could compromise the functionality and safety of the medical device. The decision to recall was made voluntarily by Medtronic Inc. to address these significant safety concerns. Detailed information regarding specific product models, specifications, and batch numbers affected is available in the "Medical Device Recall Event Report Form" provided by the NMPA. This action underscores the manufacturer's commitment to patient safety and adherence to medical device regulations under the NMPA's oversight.

Company: https://www.globalkeysolutions.net/companies/medtronic-inc/398d5f72-c7d2-4c97-94fc-fbef4cf2336d/