Medtronic Inc. Initiates Class I Recall of Extracorporeal Blood Pumping Console Due to Voltage Specification and Component Failure Risks

On March 25, the National Medical Products Administration (NMPA) issued an announcement, notifying that Medtronic has voluntarily recalled some of its non-compliant products, including the Centrifugal Pump Blood Control Monitoring System.

The specific situation is as follows:

Medtronic Inc. Voluntarily Recalls Centrifugal Pump Blood Control Monitoring System Extracorporeal Blood Pumping Console

Medtronic (Shanghai) Management Co., Ltd. reported that due to issues involving specific models and specific batches of products, there is a discrepancy between the maximum voltage input of the backup component and the original component, leading to insufficient voltage specifications in the main system controller module. Additionally, transient voltage spikes in the system controller module can cause failures in the DC-DC converter and D88 diode. The manufacturer, Medtronic Inc., has initiated a voluntary recall of the Extracorporeal Blood Pumping Console (Registration Certificate No.: Guo Med Reg In 20193101601).Recall level is Level 1.

Attachment:Medical Device Recall Incident Report Form