On March 25, the State Food and Drug Administration issued an announcement on Medtronic's voluntary recall of the centrifugal pump blood control monitoring system. Among them, the batch of products involved in the sale of 257 units in China.
From the official website of the State Drug Administration
It is understood that the product is suitable for pumping blood through the cardiopulmonary bypass surgery through the extracorporeal circulation pipeline. According to the recall notice, the maximum voltage input difference between the spare component and the original component of the device caused insufficient voltage specifications of the host system controller module. In addition, transient voltage spikes in the system controller module can cause problems with DC-DC converter and D88 diode failure. These issues can cause problems such as instrument shutdown, non-functional user interface, or even smoke and a burning odor before and during use.
It is reported that the recall is a first-level recall. Chen Hongyan, secretary general of the Medical Supplies Branch of the China International Travel Health Care Association, once said in an interview with the People's Daily health client that the first level is the most serious type of recall, which means that the use of these devices may lead to serious injury or death. According to the Administrative Measures for the Recall of Medical Devices issued by the former State Food and Drug Administration (since May 1, 2017), it is clearly stipulated that the third-level recall is less likely to cause harm to the use of the medical device but still needs to be recalled; the first-level recall is that the use of the medical device may or has caused serious health hazards.
According to the incomplete statistics of the People's Daily health client, from September 27, 2021 to March 27, 2021, in the past six months, the State Food and Drug Administration has reported a total of 210 active recalls of illegal medical device products, of which Medtronic and its subsidiaries have a total of 10 active product recalls, 6 first-level, and 4 second-level products in half a year, involving neural monitoring tracheal intubation, insulin injection pump, laminated stent system, etc.
According to public information, Medtronic was founded in 1949, according to the "2021 Global Medical Device 100 List" released by Medical Design and Outsourcing, Medtronic topped the list with an operating income of $30.117 billion.
The person in charge of quality of a medical device company once said in an interview with the People's Daily health client that the medical device recall system has actually become a very mature effective model for managing medical devices with hidden dangers in the world, medical device products have its particularity, the production process is very complicated, and it is inevitable that defective products will occur. Proactive recalls after problems are identified are responsible and reduce the risk of medical devices in use.
