HeartMate II and HeartMate 3 LVAS Recall Follows 14 Deaths, Hundreds of Injuries

Federal regulators indicate that more than 13,500 Heartmate LVAS (Left Ventricle Assist Systems) distributed over the past decade may lead to the development of obstructions, which prevent the flow of blood through the heart, potentially leading to serious injuries or death.

A HeartMate II and HeartMate 3 Left Ventricular Assist Systems (LVAS) recall notice was posted by the U.S. Food and Drug Administration (FDA) on April 15, indicating that an accumulation of biological material in the device, typically occurring over two years or more, can obstruct the devices and reduce its effectiveness in aiding blood flow.

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.

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

HeartMate II and 3 LVAS Blockage Risks

The Heartmate device manufacturer, Thoratec Corporation, first warned about the HeartMate obstruction and blood flow problems in an Urgent Medical Device Correction Letter issued on February 19, which urged healthcare professionals to pay close attention to any low flow alarms, which is the first sign of outflow obstruction.

Thoratec’s warning letter indicates the HeartMate II and HeartMate 3 Left Ventricular Assist Systems (LVAS) may be prone to an issue known as Extrinsic Outflow Graft Obstruction (EOGO), which occurs when biological material accumulates between the HeartMate Outflow Graft and the Outflow Graft Bend relief or other components added during surgery.

This buildup has the potential to obstruct the device, reducing its effectiveness in supporting heart function, the manufacturer warns. This may trigger alarms signaling low blood flow and compromise the device’s ability to assist the heart adequately.

After the disclosure of the nearly 300 adverse events, the FDA updated the recall on April 14, giving it a Class I designation, indicating that use of affected LVAS may cause serious adverse health consequences and, in worst cases, could result in death.

HeartMate LVAS Recall

The recall impacts approximately 13,883 HeartMate II and HeartMate 3 LVAS distributed throughout the U.S. to healthcare facilities and hospitals starting as early as April 21, 2008. It includes the following models:

• HeartMate II Sealed Outflow Graft with Bend Relief;
• HeartMate II LVAS Implant Kit;
• HeartMate II LVAS Implant Kit (Unsealed Outflow Graft with Bend Relief);
• HeartMate II LVAS Implant Kit (with RSOC Controller);
• HeartMate II LVAS Implant Kit (with Sealed Graft);
• HeartMate II LVAS Implant Kit (used for pump exchange, No Graft);
• HeartMate 3 Sealed Outflow Graft with Bend Relief; and
• HeartMate 3 LVAS Implant Kit

While the devices are not being removed from the market, healthcare professionals are being instructed to complete and return an acknowledgement form included in the February Urgent Medical Device Correction Letter, and to refer to the additional guidance provided on how to identify and resolve low flow events caused by the outflow graft obstruction.

Individuals with questions can contact Abbott/Thoratec Corporation at (844) 692-6367. 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.

HeartMate 3 LVAD Problems

The FDA has documented a long history of problems with the HeartMate 3 devices in a series of warnings and recalls. Abbott warned of problems with the HeartMate in a Medical Device Advisory back in December 2019, following numerous reports of the devices losing power when changing the controller on the pump if the modular cable is connected at an incorrect angle.

In that recall, Abbott warned that when the modular cable is incorrectly connected, there is a potential for electrical contact to cause a blown fuse. At the time the HeartMate recall was announced, the manufacturer indicated it was aware of at least two serious injury reports involving the presence of static electricity causing power loss to patients.

The FDA also issued a HeartMate 3 recall in May 2018, warning that the outflow graft assembly may experience a malfunction causing the graft to twist and occlude, or close up, over time. An occlusion of the outflow graft may reduce or stop the pump flow. Stopping the pump can lead to serious side effects, such as bloods clots, or even death.

Prior to this, the FDA announced a HeartMate II LVAS Pocket System Controller recall on May 23, 2017 warning that Abbott Laboratories’ has received at least 70 reports of problems where the device malfunctioned after patients tried to change the controller improperly or too slowly. The problem had resulted in at least 26 deaths and 19 injuries at the time of the recall.