Abbott Heartmate 3 Recall Issued After Reports of Blood Leaks, Air Embolism and Heart Failures

Manufacturer indicates that healthcare professionals should keep an alternative left ventricle assist device (LVAD) on standby in the event of a Heartmate 3 failure.

Amid continuing concerns about serious problems with Heartmate heart pumps, which have resulted in a number of recent recalls and safety warnings, the manufacturer now warns some of the devices have been linked to dozens of reports of blood leaks or air entering the system while in use, increasing the risk of serious injuries or death.

The U.S. Food and Drug Administration (FDA) posted information about an Abbott HeartMate 3 recall on May 15, warning that blood leakage or the entry of air into the heart pump can compromise the integrity of blood flow, potentially resulting in extended surgery times, hemorrhaging, right heart failure, or air embolism

The agency indicates the manufacturer has become aware of at least 81 incidents of blood leaks or air entering the devices, resulting in 70 injuries and two deaths linked to the HeartMate 3.

The recalled Heartmate devices are designed to help the heart pump blood from the left ventricle into the aorta, aiding in blood circulation throughout the body. The medical devices provide short- and long-term assistance to adult patients experiencing severe left ventricular heart failure who are awaiting a heart transplant, recovering from cardiac events, or as a permanent solution when a heart transplant is not available.

HeartMate 3 LVAD Air Embolism and Bleeding Risks

The device manufacturer, Abbott, first warned about the HeartMate problems in an Urgent Medical Device Correction Letter issued on March 20, which cautioned cardiologists and physicians about the potential for blood leakage or air entering the inflow cannula and the apical cuff.

The letter indicated that if an individual with a HeartMate 3 Left Ventricular Assist Device (LVAD) experiences an air or blood leak, several severe complications may arise such as device failure, the need for surgical intervention, increased infection risk and heart failure.

Air leaks can introduce bubbles into the bloodstream, potentially causing air embolisms that block blood vessels and can lead to organ damage, strokes, or heart attacks. Blood leaks may result in significant internal bleeding, which can cause a sudden drop in blood pressure, decrease organ perfusion, and lead to shock, potentially resulting in fatal outcomes.

Such leaks can also reduce the device’s efficiency, diminishing its ability to assist the heart and exacerbate symptoms of heart failure. In some cases, substantial or uncontrollable leaks may require further surgical intervention to repair or replace parts of the LVAD, increasing surgical risks and recovery time.

Moreover, leaks can heighten the risk of infection, which is particularly dangerous in HeartMate LVAD patients and often requires prolonged antibiotic treatment or additional surgeries. Blood leaks can strain the cardiovascular system, sometimes leading to right heart failure; where the right side of the heart fails to pump blood effectively to the lungs, worsening the patient’s overall health condition.

FDA Categorized HeartMate 3 Recall as Class I

The recall impacts approximately 882 HeartMate 3 LVAS distributed throughout the U.S. to healthcare facilities and hospitals from March 1, 2021 through March 13, 2024. Given serious risks associated with the device, the FDA has categorized the HeartMate 3 recall as a Class I medical device recall, suggesting that continued use of the product may result in severe injury or death.

While the devices are not being removed from the market, healthcare professionals are being instructed to carefully monitor patients for such events and to follow standard surgical processes and the existing instructions for use (IFU) by adjusting the pump position, waiting for the natural tendency of blood to coagulate or upon reversal of anticoagulation, adding surgical materials, and exchanging the apical cuff, the pump, or both.

The manufacturer further instructed medical professionals to always have a complete backup system readily available when using the HeartMate 3 device in the event of an emergency.

Individuals with questions can contact their local Abbott representative or call 612-346-3514. Healthcare providers and consumers are encouraged to report any adverse reactions or issues encountered while using these devices to the FDA MedWatch Adverse Event Reporting Program.

Long History of HeartMate Problems

The FDA has documented a long history of problems with the HeartMate 3 devices in a series of warnings and recalls.

In one of the most recent announcements, a HeartMate II and HeartMate 3 Left Ventricular Assist Systems (LVAS) recall notice was posted by the FDA on April 15, indicating that an accumulation of biological material in the device, typically occurring over two years or more, can cause obstructions, reducing its effectiveness in aiding blood flow.

According to the FDA warning, HeartMate LVAS obstruction problems have been linked to 273 injury reports and at least 14 deaths.

The FDA also announced a HeartMate Touch System recall on March 11, indicating that an error may cause the communication system to disconnect from the patient’s HeartMate controller while a “pump stop” command is running.

At the time the HeartMate recall was announced, the manufacturer indicated that it was aware of at least two serious injury reports involving the presence of static electricity causing power loss to patients.

In December 2019, the FDA issued yet another HeartMate 3 Medical Device Advisory, indicating that the devices could lose power when changing the controller on the pump, if the modular cable is connected at an incorrect angle.

In May 2018, the U.S. Food and Drug Administration (FDA) announced a Class I HeartMate 3 recall, impacting more than 5,000 devices, due to the potential for the outflow graft assembly to experience a malfunction causing the graft to twist and occlude, or close up, over time. Officials warned occlusion of the outflow graft may reduce or stop the pump flow which could lead to serious side effects, such as bloods clots, or even death.

In 2017, Abbott recalled 29,000 HeartMate II LVAS Pocket System Controllers following 26 reports of patient deaths due to the devices malfunctioning after patients tried to change the controller improperly or too slowly. The devices were not withdrawn from the market, rather, Abbott provided patients with a fully upgraded system with new yellow alignment markings and new drivelines.

Given the growing number of HeartMate problems dating back to 2011, lawyers are reviewing potential HeartMate lawsuits for those who have suffered injuries or for families of individuals who have suffered a wrongful death caused by problems with the HeartMate devices.

To determine if you or a loved one may be eligible for a HeartMate recall lawsuit, submit information about your potential claim for a HeartMate recall lawyer to review.