FDA issues highest-level alert for heart pumps connected to 49 reported deaths

The Food and Drug Administration (FDA) has issued a Class I recall, the highest-level alert, for heart pumps that have been linked to nearly 50 deaths.

Impella heart pumps are used for short term support of pumping blood in the chambers of 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 warned of the risk and the company has advised customers to review new instructions.

The agency noted that the “recall is a correction, not a product removal.”

“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.

The pumps have been in use 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.

The letter asked customers to “adhere to new and revised warnings” which include carefully positioning the pump catheter during operative procedures, using imaging when advancing the pump catheter, using special care when inserting the pump in high-risk patients and review the warnings listed in the pump’s instructions.

The letter also asks all employees at facilities using the pumps to be notified of the recall correction and notify facilities where products have been sent.

Abiomed, the company that produces the pumps, said it has already updated its instructions for the Impella system “to further address the potential risk of a rare complication, left ventricular (LV) perforation.”

“With patient safety top of mind, our IFU has been updated with stronger technical guidance around implantation and repositioning and emphasizes specific cardiac and peripheral vascular anatomic considerations when implanting Impella,” the company said in an emailed statement.

Updated April 2 at 3:10 p.m.

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