The FDA has issued a Class I recall, the highest-level alert, for heart pumps connected to nearly 50 deaths.
Impella heart pumps are used to help pump blood in the heart's ventricles during medical procedures or after a severe heart attack.
The Impella Left Sided Blood Pumps are affected because the "pump catheter may perforate (cut) the wall of the left ventricle in the heart." The FDA has cautioned about the risk and the company has recommended customers to review new instructions.
"During operations, the Impella device could cut through the wall of the left ventricle. The use of the affected Impellla pumps may cause serious adverse health consequences, including left ventricle perforation of free wall rupture, hypertension, lack of blood flow, and death," the FDA’s release said. So far, there have been 129 serious injuries reported and 49 reports of death.
129 serious injuries have been reported, along with 49 deaths.
The pumps have been used from Oct. 10, 2021 to Oct. 10, 2023. More than 66,000 devices have been recalled in the U.S. after a firm sent all affected customers an urgent medical correction letter.
A letter asked customers to “adhere to new and revised warnings” including carefully positioning the pump catheter, using imaging when advancing the pump catheter, using special care in high-risk patients, and reviewing the pump’s instructions.
The letter also requires all employees at facilities using the pumps to be notified of the recall correction and notify facilities where products have been sent.
