HeartMate 3 Recall Issued Over Pump Flow Failures, Risk Of Fatal Blood Clots

The FDA has announced a class I medical device recall for the HeartMate 3 Left Ventricular System, due to a risk that a malfunction in the outflow could cause the pump to stop. 

The HeartMate 3 recall was announced on May 22, indicating that nearly 5,000 devices are being removed from the market due to problems that could lead to potentially fatal adverse events. The FDA did not state whether there have been any injuries or deaths related to the recall recalled devices.

The Abbott Laboratories HeartMate 3 Left Ventricular Assist System helps to deliver blood from the heart to the rest of the body. It is used to support patients who are at risk of death from end-stage left ventricular heart failure. Patients typically use the device for short-term periods, such as when they are awaiting a heart transplant.

The HeartMate 3 system includes a blood pump that is implanted into the pericardium; the space around the heart. It also includes an outflow graft that connects the pump to the aorta.

The recall notice warns 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.

An FDA Class I recall designation is only used when problems with a medical device pose a risk of serious injury or death to the user.

Abbott recalled the HeartMate II system last year, after determining that a malfunction to the controller may pose a risk for patients. That recall was linked to 26 deaths and 19 injuries, impacting more than 29,000 devices. More than 70 reports of problems were received related to that recall.

An occlusion in the outflow graft can also cause a persistent low flow alarm to sound. Health officials warn patients who hear the persistent low flow alarm should contact the doctor managing their HeartMate 3 immediately. However, the HeartMate 3 should not be removed because of this issue. Instead, it should be monitored continuously.

This latest Heartmate recall involves 4,878 units with model/item numbers 106524US, 106524, and 10652INT. It includes all lots with all manufacturing dates distributed September 2, 2014, to present.

Abbott Laboratories sent an Urgent Medical Device Recall notification to doctors on May 21. The notice alerted doctors of the potential malfunction and provided instructions to manage patients who are getting the device or patients who already have the device implanted.

Abbott does not recommend the HeartMate 3 be removed. Instead, patients should have frequent follow-ups and surveillance exams. If the low flow alarm sounds, a CT angiogram should be done immediately to determine if there is an occlusion in the outflow graft. Similarly, TTE imaging can be used to assess occlusions, which may require surgery to repair the outflow graft.

Patients or customers who want more information about the recall can contact Abbott Mechanical Circulatory Support Clinical Specialist or MCS HeartLine at 1-800-456-1477. Side effects related to the recalled HeartMate3 should be reported to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.