Manufacturer says it can puncture the heart and has been linked to 49 deaths, 129 serious injuries
By Physician’s Briefing Staff HealthDay Reporter
MONDAY, April 1, 2024 (HealthDay News) — The U.S. Food and Drug Administration has issued a warning regarding a heart pump that could perforate a wall in the left ventricle if used incorrectly.
The left-sided Impella heart pump is made by Abiomed, a subsidiary of Johnson & Johnson MedTech, and has already been linked to 129 injuries and 49 deaths.
“The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death,” the statement said, although it adds that “this recall is a correction, not a product removal.”
The advisory informs those implanting the Impella devices about revised instructions for use, including “carefully position the pump catheter during operative procedures.”
“During operations, the Impella device could cut through the wall of the left ventricle,” the company warned in its statement. “The use of the affected Impella pumps may cause serious adverse health consequences, including left ventricle perforation or free wall rupture, hypertension, lack of blood flow, and death.”
According to the latest Abiomed advisory, anyone undergoing a procedure using Impella left-sided blood pumps should be aware of the new instructions for use, especially people with heart disease, the elderly, and women.
But Public Citizen, a consumer advocacy group, issued a statement calling for a full ban on the devices. Despite dozens of severe injuries and deaths, “the FDA has allowed them to remain in use,” the group said. “Moreover, there are serious and ongoing concerns about whether there are clinically meaningful survival benefits that outweigh the risks of these left ventricular assist devices.”
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