China NMPA Product Recall - Heart Suction Tube

Medtronic, Inc., in conjunction with Medtronic (Shanghai) Management Co., Ltd., has initiated a voluntary Class II recall of specific models and batches of its Heart Suction Tube (Registration Certificate No.: 20152141672). The recall, reported on October 15, 2021, addresses a critical product defect where the guidewire probe within the heart sump tube may pierce the tip of the left ventricular tube. This malfunction poses a significant risk of tissue damage to patients if it occurs prior to a surgical procedure. This action falls under the oversight of the National Medical Products Administration (NMPA). While no specific inspection dates are mentioned as this is a manufacturer-initiated recall, the company is taking proactive steps to mitigate patient risk. The required action involves the recall of all affected Heart Suction Tube units. Further detailed information regarding the specific affected product models, specifications, and batch numbers is available in the accompanying "Medical Device Recall Event Report Form." This voluntary recall underscores Medtronic's commitment to patient safety and product integrity.