| Developers: | Abbott Laboratories |
| Branches: | Pharmaceuticals, Medicine, Healthcare |
Content |
HeartMate is a device that supports the left ventricle of the heart in patients with severe heart failure. The device implants directly to the heart and adopts the function of pumping blood. HeartMate and similar solutions are called artificial hearts. Initially, this device was used to maintain blood circulation before a heart transplant, and then it began to be implanted on an ongoing basis in patients who are contraindicated in heart transplantation due to age or other factors.
2025: Dangerous Defect: Device May Suddenly Shut Down
On April 24, 2025, the U.S. Food and Drug Administration (FDA) announced that Abbott was recalling defective artificial heart modules. The use of these products can result in severe harm to the health of patients or even provoke death.
The issue affects the HeartMate Mobile Power Unit (MPU), which is used in conjunction with the HeartMate 3 Left Ventricular Assist System (LVAS) and HeartMate II LVAS systems designed to assist circulation and maintain left ventricular function of the heart. The MPU provides power to the controller that controls the operation of the pump.
The notice FDA says that defective MPUs may experience various malfunctions during operation. These include sudden outages, spontaneous restarts and inability to turn on. In this case, various alarms may appear - for example, an indicator in the form of a yellow wrench lights up or a warning about the absence of external power is displayed.
If the defective MPU does not provide power, the backup battery in the system controller will be able to keep the pump running for 15 minutes. After that, an artificial heart will stop. This can lead to serious adverse health effects, such as hemodynamic changes (impaired blood flow and blood circulation), thromboembolism (blockage of a blood vessel by a blood clot), or death. As of April 2025, there are no reports of any serious injuries or deaths associated with the problem.
The defect affects MPUs that spread from April 2024 to February 2025. Abbott will replace such devices.[1]
2021: The first implantation of the HeartMate III system in Russia to a child
In April 2021, the first implantation of the auxiliary blood circulation system (artificial left ventricle of the heart) to a child was carried out in Russia. It was performed by a team of doctors of the Sverdlovsk Regional Clinical Hospital No. 1 under the leadership of the head of the department of pediatric cardiac surgery Konstantin Kazantsev. Russian doctors were advised by specialists from the Institute of Clinical and Experimental Medicine (Prague, Czech Republic): director of the cardiology center, professor Jan Pirk and doctor of the department of anesthesiology and resuscitation Thomas Kotulyak.
In September 2020, a nine-year-old patient was admitted to the hospital. At the end of summer, he suffered an infection, this caused a complication on the heart - infectious endomyocarditis. The boy was admitted with acute heart failure. The first operation was performed on the same day - doctors replaced the mitral valve destroyed by the infection with a mechanical prosthesis.
The child was transferred to artificial circulation for several days to restore the work of the left ventricle of the heart. After this operation, the patient's rehabilitation began and there was even a positive trend, but after a month the ability to pump blood from the heart decreased again.
As a result, the HeartMate III system was successfully implanted. This technology is based on a motor with a rotor levitating in a magnetic field, which pumps blood from the left ventricle to the aorta without touching other parts of the device. This practically excludes all complications associated with damage to blood components, noted in the Ministry of Health of the Russian Federation. The only thing a child will need to get used to is a small bag with a pair of replaceable batteries connected to the device using a cable brought out. For uninterrupted operation of the system, they need to be recharged once a day, the department added.[2]
2019: Recall of defective devices
In early December 2019, Abbott sent out an alert to customers regarding the HeartMate 3 left ventricular accessory circulation machine. Due to the defect of the mobile power supply, these systems can suddenly turn off during operation. Defective equipment is being recalled.
It turned out that a mobile power supply unit connected to the HeartMate 3 left ventricular device of auxiliary blood circulation could irreversibly suffer due to the effects of static electricity. Severe power loss and damage to the power supply can threaten the patient's life: Abbott has already received two reports of serious adverse events as a result of a system failure. There have been no reports of deaths related to defective systems so far.
Abbott's staff plans to conduct tests at all facilities to reduce excess static electricity. In cases where the patient is awake, it is recommended to use battery power instead of a mobile power supply. If the device emits an alarm, patients are also advised to switch to the HeartMate 3 battery.
In addition, Abbott provided clients with recommendations that prevent excessive static electricity from accumulating on the device's body. Experts advise switching the system to battery power before folding or changing sheets, removing laundry from the dryer, transferring legs to the carpet, touching TV or computer screens. The company strongly recommends using moisturisers, laundry dryers, fabric softeners and skin moisturizers to reduce the accumulation of static electricity.
The security notification applies only to the HeartMate 3 mobile power supply. HeartMate 2 devices are not affected by these warnings.[3]
2017: Patient deaths
In May 2017, Abbott Laboratories announced a massive recall of controllers for HeartMate II artificial hearts, the use of which led to the death of patients.
In total, the manufacturer received 70 reports of "incidents involving a malfunction of the controller after replacement." In 19 cases, patients received various injuries. In addition, 26 deaths were recorded when people tried to replace the controller on their own, the Food and Drug Administration (FDA) said.
 | "Such changes need to be made quickly and done in hospitals as otherwise there could be a serious problem for elderly or inexperienced patients. For them, a slow or incorrect replacement can lead to serious injury or death, "the department said, citing a message from Abbott. |  |
The company is recalling 28,882 controllers for HeartMate II. They need to install new software and alerting system. This equipment has the numbers 105109, 106015, 106762 and 107801, it was sold from July 2012 to December 2016. Defective controllers ceased production in March 2017.
In 2014, the FDA reported four deaths and five injured people due to controller issues for HeartMate II.[4]
Notes
- ↑ Heart Pump Accessory Removal: Abbott Removes HeartMate Mobile Power Unit due to Instances of Sudden Power Loss
- ↑ In the Sverdlovsk region for the first time in Russia, an auxiliary blood circulation system was installed for a child
- ↑ Abbott issues field safety notice for Heartmate 3 LVAS power unit
- ↑ 26 patients have died after replacing controller for Abbott blood pump at home
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