Medtronic Issues Another Level 1 Recall. The Shanghai Medical Products Administration recently announced that due to false-negative response issues with its NIM Vital nerve monitoring system, Medtronic (Shanghai) Management Co., Ltd. has voluntarily recalled the nerve monitoring system (registration certificate number: G20233070120). The recall level is Level 1, the highest level for medical device recalls.
As of now, the product has sold 21 units in China. Medtronic China stated that it will upgrade all nerve monitors with software version v1.4.3 or earlier on the market, and the recall does not involve product discontinuation or return. According to the reporter's statistics, this is already Medtronic's third Level 1 recall in China this year.
May cause risks such as surgical delays and nerve damage.
According to customer feedback received by Medtronic, the NIM Vital nerve monitor has a false-negative response issue (no EMG tone triggered when the probe contacts the nerve), which may lead to risks such as surgical delays and nerve damage. Medtronic has decided to release a software update for all affected nerve monitors. Based on this, Medtronic (Shanghai) Limited is voluntarily recalling its manufactured nerve monitor (registration certificate number: GuoXieZhuJin 20233070120). The recall level is Class I.
The "Measures for the Administration of Medical Device Recalls" stipulates that medical device recalls are divided into three levels based on the severity of the defect. A Level 1 recall is the highest level, meaning that the use of the medical device may or has already caused serious health hazards.
The aforementioned nerve monitor is only compatible with Medtronic accessories. The product is used intraoperatively to identify, locate, and monitor motor and mixed nerves emanating from cranial and spinal nerves, and to record intraoperative electromyography (EMG) signals. The production (or import into China) quantity of this product is 43 units, with 21 units already sold in China. To date, Medtronic China has not received any complaints or adverse events related to patient injuries caused by this issue.
Regarding the recall requirements and handling methods in China, Medtronic China stated that it will send a medical device voluntary recall notification letter to all affected platform providers, who will then notify all downstream dealers and hospitals affected, explaining the background and requirements of this recall; upgrade all neuromonitors on the market with software version v1.4.3 or earlier. This recall does not involve the discontinuation or return of the product.
There have been three Class I recalls in China this year.
The product recall system is considered the "last line of defense" for product safety, and the recall of medical device products is an important measure for post-market risk control.
Statistics from the Beijing News reporter show that, since the second half of last year, among the medical device recall information announced by the National Medical Products Administration, Medtronic had the most voluntary recalls, with a total of 26, significantly higher than Olympus (15), Philips (6), Siemens (3), and other peers.
China's medical device recalls are divided into three levels: Level One Recall (the use of the medical device may or has already caused serious health hazards); Level Two Recall (the use of the medical device may or has already caused temporary or reversible health hazards); Level Three Recall (the use of the medical device presents a smaller possibility of harm but still requires a recall).
According to the reporter's statistics, since the beginning of this year, Medtronic has issued three highest-level recalls in China. In addition to the recent recall of nerve monitors, in May this year, Medtronic Navigation Inc. voluntarily recalled its neurosurgical navigation systems (Registration No. 20183010514), spinal surgical navigation systems (Registration No. 20183010510), and ENT surgical navigation systems (Registration No. 20183010507) due to potential software anomalies that could cause incorrect biopsy needle depth settings. In March this year, Medtronic voluntarily recalled its external drainage devices (Registration No. 20183140246) due to risks such as potential disconnection of tubing. The first two Level 1 recalls involved a total of 12,569 products sold in China, of which 12,367 were external drainage devices sold in China alone.
As a globally renowned medical device company, Medtronic's innovative technologies span four medical fields: cardiovascular, surgical and critical care, neuroscience, and diabetes, extending to more than 70 key disease areas. Its operations cover over 150 countries and regions worldwide, with more than 90,000 employees. According to its official website, every second, two patients around the world benefit from Medtronic's medical technologies or therapies. The company’s fiscal year 2024 report (covering the period from April 29, 2023, to April 26, 2024) shows that total revenue for the reporting period reached $32.364 billion. Revenue from emerging markets, including Greater China, amounted to $5.823 billion, representing a year-on-year increase of 6.9%. The cardiac and vascular business became the only segment with revenue exceeding $10 billion, reaching $11.831 billion.
Reporter Zhang Xiulan from The Beijing News
Proofread by Mu Xiangtong