The Food and Drug Administration (FDA) has issued a new warning over a device that could perforate the heart and has been linked to 49 deaths and 129 serious injuries.
The FDA sent out its highest-level alert for Impella Left Sided Blood Pumps made by Abiomed, Inc., a Johnson & Johnson subsidiary.
“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,” according to the March 2024 FDA advisory.
But the alert also stated that “this recall is a correction, not a product removal.” This means that Abiomed has recalled its instructions for use of the devices, but the heart pumps are still available on the market.
In addition to the risk of heart perforation, the heart pumps could cause other adverse health consequences, including free wall rupture, hypertension, lack of blood flow, and even death, the FDA says.
Dubbed “the world’s smallest heart pump,” the device is used during high-risk catheter-based procedures called percutaneous coronary interventions (PCI). The pump, which has a catheter with a small hook on the end, is inserted through the leg artery and guided into the left ventricle of the heart.
“Once in place, the Impella pump is turned on, providing support to the heart while monitoring the pumping activity. The Impella heart pump mimics the natural pathway of blood flow to the heart from the ascending aorta, increasing blood pressure while unloading the heart and providing more blood supply to vital organs such as the brain and kidneys,” according to the company’s YouTube video.
The risk of heart perforation first emerged when Abiomed issued an alert to physicians in a technical bulletin in October 2021. But the company violated protocols by failing to disclose the information to the FDA when it first discovered the risk, according to officials.
After the violation, the FDA followed up with an investigation of the Abiomed facility in September 2023 and issued a warning letter to the company shortly after. This prompted the company to send out an Urgent Medical Device Correction letter in December 2023. It warned that any patients undergoing a procedure using the Impella pumps should be aware of the new instructions for use, especially people with heart disease, particularly the elderly and women.
Despite the FDA’s urgent recall, the heart pumps remain on the market. But consumer advocacy group Public Citizen has called for a full ban on the devices.
“Given the ongoing safety concerns about Impella left ventricular assist devices and this new recall, it is woefully inadequate to revise an instruction manual and to tell cardiologists to be more careful. The use of these left ventricular assist devices should be stopped,” according to a statement by Dr. Robert Steinbrook, director of Public Citizen’s Health Research Group.
More than 66,000 units in the U.S. are affected by the alert.
The devices include the Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist, and Impella LD.
The heart pumps were distributed from October 10, 2021, to October 10, 2023.
