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MONDAY, April 1, 2024 (HealthDay News) — A new warning has been issued about a heart pump whose use could cause a hole in the heart.
The device has already been linked to more than 100 injuries and 49 deaths.
These left-sided Impella heart pumps are manufactured by AbioMed, a subsidiary of Johnson & Johnson MedTech. Abiomed posted a new warning about the devices on the U.S. Food and Drug Administration (FDA) website.
“The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices can result in serious injury or death,” the statement said, though it also added that ” This recall is a repair, not a disposal product”.
The notice informs those implanting Impella devices of revised instructions for use, including “carefully installing the pump catheter during surgical procedures.”
These Impella pumps are like a long straw inserted into the heart. They are used during high-risk cardiovascular procedures (for example, during certain types of heart attacks) to help maintain adequate blood flow from the heart to the body.
The pump is introduced through the main heart vessels and reaches the heart’s left ventricle, the organ’s main pumping chamber.
“AbioMed is recalling its Impella left-sided blood pumps because the pump’s catheter can puncture (cut) the wall of the left ventricle in the heart,” the company warned in its statement. “During the operation, the Impella device may cut the wall of the left ventricle.”
“Use of the affected Impella pumps may result in serious adverse health consequences, including left ventricular orifice or free wall rupture, high blood pressure, reduced blood flow, and death,” the warning said.
So far, 129 patients have reported serious injuries related to the devices, and 49 patients have died.
The issue first surfaced in a technical bulletin for doctors in October 2021, but was not reported to the FDA at that time. An FDA spokesperson told CNN that failing to do so violated agency protocol.
The FDA inspected Abiomed’s facilities in September 2023 and issued its warning letter to the company shortly thereafter.
According to the latest advice from Abiomed, anyone undergoing the Impella left sided blood pump procedure should be aware of the new instructions for use, especially people with heart disease, the elderly and women.
But consumer advocacy group Public Citizen issued a statement calling for a complete ban on the devices.
Despite dozens of serious injuries and deaths, “the FDA has allowed them to remain in use,” the group said. “In addition, there are serious and continuing concerns about whether there are clinically significant survival benefits that outweigh the risks of these left ventricular assist devices.”
Dr. Robert Steinbrueck heads the Public Citizen Health Research Group.
“Given the continued safety concerns about Impella left ventricular assist devices and this new recall, it is inadequate to review an instruction manual and ask cardiologists to be more careful,” Steinbrueck said in a statement. “The use of these left ventricular assist devices should be discontinued.”
“There is an urgent need for better treatments,” Steinbruch said, and “in the future, these devices should be used only in patients enrolled in randomized, controlled trials that compare the devices to medical (drug) management.”
more information
Learn more about heart attacks and their treatment at Cleveland Clinic.
Sources: Abiomed, Statement, March 21, 2024, and Technical Bulletin, October 2021; US Food and Drug Administration, Warning Letter, October 10, 2023; Public Citizen, Statement, March 29, 2024; cnn
