Beijing News (reporter Zhaohui Zhang) The order to recall information released on the official website of the National Medical Products Administration shows that Medtronic Navigation, Inc. (hereinafter referred to as Medtronic) voluntarily recalled its neurosurgical navigation systems, spinal surgical navigation systems, and ENT surgical navigation systems. This recall is classified as a Class I recall, the most severe level, indicating potential serious health hazards. Following the announcement, at noon today, Medtronic's stock price closed at $81.38 per share, down 5.11%.
Medtronic (Shanghai) Management Co., Ltd. reported that due to a software anomaly which may cause incorrect depth setting of the biopsy needle, the manufacturer Medtronic has initiated a voluntary recall of its Cranial Treatment Guidance System (China Medical Device Registration No. 20183010514), Spine Treatment Guidance System (China Medical Device Registration No. 20183010510), and ENT Treatment Guidance System (China Medical Device Registration No. 20183010507).
The Medical Device Recall Report shows that the recall covers a global scope, with 202 units of the affected products sold in China. The three recalled products are respectively used for optical or electromagnetic navigation of anatomical structures during open or percutaneous neurosurgical procedures; optical navigation of anatomical structures during open or percutaneous spinal surgical procedures; and electromagnetic navigation of anatomical structures during open or percutaneous ENT (Ear, Nose, and Throat) surgical procedures.
Medtronic stated that if clinicians encounter software anomalies and operate based on the displayed error messages, there is a possibility of incorrectly setting the biopsy needle's depth limit, which could potentially lead to permanent nerve damage. In the customer complaints received by Medtronic, the abnormal conditions have been identified, causing brief delays in surgery, but no serious patient injuries have been reported.
The regulatory information released by the National Medical Products Administration shows that on December 5, 2023, Medtronic Navigation Inc. voluntarily recalled three products: ENT surgical navigation systems, spinal surgical navigation systems, and neurosurgical navigation systems. The reason for the recall was due to software anomalies in version 2.0 and 2.0.1 of the StealthStation S8 software application.
According to incomplete statistics by reporters from The Beijing News, since the beginning of this year, the National Medical Products Administration (NMPA) has issued five recalls involving Medtronic products. There were 17 recalls in 2023, six in 2022, and ten in 2021. These recalls included devices such as implantable deep brain neurostimulators, ENT surgical navigation systems, orthopedic spinal surgery toolkits, and deep brain neurostimulator physician programmers, covering medical devices across multiple disciplines including neurology, surgery, ENT, and cardiovascular fields.
Among them, in March 2022, the National Medical Products Administration announced that Medtronic decided to initiate a Level 1 recall of the Extracorporeal Blood Pumping Console, a centrifugal pump blood control monitoring system (ECMO) product. This malfunction may cause the instrument to shut down, including a black screen, smoke emission from the device, and a burning smell during use. Industry insiders interpreted that for ECMO machines, a black screen or the blood pump stopping means the machine cannot properly simulate human blood circulation. Although the probability is low, the consequences are extremely severe.
Medtronic, founded in 1949 and headquartered in the United States, is the leading global medical device company, with business covering more than 150 countries and regions worldwide.
Proofread by Zhao Lin