Abbott/Thoratec HeartMate 2 & HeartMate 3 Recalls

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What are the Thoratec/Abbott HeartMate 2 and HeartMate 3 Left Ventricular Assist Devices?

The HeartMate Left Ventricular Assist Devices or “LVADs” are pumps implanted into the chest to assist the function of a failing heart without replacing the heart itself. The HeartMate LVADs operate parallel to the heart and assist the weakened left ventricle by taking blood from the left ventricle and moving it to the ascending aorta. The HeartMate 2 is an axial-flow rotary pump (non-pulsatile) and the HeartMate 3 is a continuous flow centrifugal pump designed to mimic the biological pulsatile flow through rapid changes in pump speed. Both the HeartMate 2 and the HeartMate 3 can be used as a bridge-to-transplantation or as a long-term destination therapy.

Components of both the HeartMate 2 and the HeartMate 3 Left Ventricular Assist Systems (“LVAS”) have been RECALLED by Abbott/Thoratec. The FDA has identified these recalls as Class 1, which is the most serious type of medical device recall by the FDA and indicates that use of these LVAS components could cause severe injury or death to patients.

The History of the HeartMate Recalls

In February 2024, Abbott sent a letter to doctors notifying them of instances of outflow graft deformation called “Extrinsic Outflow Graft Obstruction” (“EOGO”) in its HeartMate 2 and HeartMate 3 LVADs. The outflow graft is a tube that carries blood from the pump to the aorta. The portion of the outflow graft closest to the pump is encased by a slightly larger tube called a “bend relief” – which keeps the outflow graft from twisting and kinking. The outflow graft is constructed of a knitted polyethylene terephthalate material that has some porosity which permits seepage of blood components into the space between the outflow graft and the bend relief. EOGO is caused by an accumulation of bio debris over time within this space which, over time, can compress the inner outflow graft and impede the flow of blood to the aorta. Patients with this EOGO condition will often receive “Low Flow” alarms on their controllers, and might feel light-headed, lose consciousness, or suffer serious neurologic injuries.

In March 2024, Abbott send a letter to doctors advising them of complaints of blood leaking out of the left ventricle or air being sucked into the left ventricle during surgeries to implant the HeartMate 3 LVAD. Once air enters the left ventricle, it can quickly embolize to the brain causing serious neurologic injuries and death. There are also multiple reports in the FDA’s publicly-available Manufacturer and User Facility Device Experience or “MAUDE” database describing problems encountered during implantation of the HeartMate 3, including loose connections at the pump-apical cuff interface and bent/asymmetrical cuff lock arms. Some of these reports describe air entering the left ventricle and embolizing to the brain, which can cause stroke or cerebral infarction and lead to permanent neurological problems and death.

Contact Meshbesher & Spence for a Free Consultation

If you or a loved one underwent surgery to implant a HeartMate 2 or HeartMate 3 LVAD manufactured by Thoratec/Abbott and:

please contact attorney Tony Nemo at Meshbesher & Spence today. Your consultation is free, and you pay nothing until our Firm recovers fair compensation for you and your family.