Ernie Mandel HealthDay Reporter

MONDAY, April 1, 2024 (HealthDay News) — A new warning has been issued regarding heart pumps that can puncture the heart if used.

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 device on the U.S. Food and Drug Administration 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. “This recall is a modification, not a removal, of the product,” it added. . ”

The advisory informs those implanting the Impella device of revised instructions for use, including “carefully positioning the pump catheter during surgery.”

These impeller pumps resemble long straws inserted into the heart. These are used during high-risk cardiac procedures (for example, during certain types of heart attacks) to help maintain proper blood flow from the heart to the body.

The pump is inserted through the main cardiovascular blood vessels into the heart’s left ventricle, the organ’s main pumping chamber.

“Abiomed is recalling the Impella left-sided blood pump due to the possibility of puncturing the pump catheter.” [cut] “During the procedure, the Impella device may penetrate the left ventricular wall,” the company warned in a statement.

“Use of the affected Impella pumps may cause serious health effects, including left ventricular perforation and free wall rupture, hypertension, insufficient blood flow, and death,” the warning added.

To date, 129 patients have reported serious injuries related to the device, and 49 patients have died.

The issue was first disclosed in a technical report to physicians in October 2021, but was not known to the FDA at the time. This was announced by an FDA spokesperson. CNN Failure to do so would be a violation of agency protocol.

The FDA inspected Abiomed’s facility in September 2023 and issued its own warning letter to the company shortly thereafter.

According to Abiomed’s latest recommendations, people undergoing procedures using the Impella left-sided blood pump, especially those with heart disease, the elderly, and women, should be aware of the new instructions for use.

However, consumer advocacy group Public Citizen issued a statement calling for an outright ban on the device.

“The FDA has allowed continued use,” the group said, despite dozens of serious injuries and deaths. “Furthermore, there are serious and continuing concerns about whether there are clinically meaningful survival benefits that outweigh the risks of these left ventricular assist devices.”

“Given ongoing safety concerns and this new recall regarding the Impella left ventricular assist device, it is woefully inadequate to revise instruction manuals and instruct cardiologists to be more careful,” Stein said. Dr. Brooke said in a statement. “The use of these left ventricular assist devices should be discontinued.”

Dr. Steinbruck added: “Better treatments are urgently needed, and in the future these devices should only be used in patients enrolled in randomized controlled trials comparing them to medical devices. ” he added. [drug] management. “

Source: Abiomed, Statement, March 21, 2024, and Technical Bulletin, October 2021. U.S. Food and Drug Administration, Warning Letter, October 10, 2023. Public Citizen, Statement, March 29, 2024. CNN

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