HeartMate heart pumps have been subject to various lawsuits due to reported malfunctions and complications. The HeartMate 3 Left Ventricular Assist System (LVAS) specifically has been recalled “after complaint reviews identified blood leakage or air entering the seal interface between the left ventricular assist device (LVAD) inflow cannula and the apical cuff,” according to the United States Food and Drug Administration (FDA).
HeartMate Heart Pump Recall
By May 2024, Abbott reported 81 incidents – including 70 injuries and two deaths – related to blood leakage or air entering the LVAD involving HeartMate 3 LVAS devices. “In all reported events, the issue was observed during implantation of the device,” the FDA noted.
Patients who need cardiac support using the HeartMate 3 LVAS System and any healthcare providers using the HeartMate 3 LVAS System for their patients need to be aware of this recall and the potential dangers of using a HeartMate heart pump device.
Heart Pump Lawsuits
However, there are actually a number of defective heart pump lawsuits against Abiomed and Abbott medical devices. Some of the devices impacted include:
- Abiomed Impella Left-Sided Blood Pump
- Abbott HeartMate 2
- Abbott HeartMate 3
The recall of Abbott’s HeartMate 3 LVAD was designated as Class I, which is the most serious type of medical device recall. And in June 2024, Abbott Medical also recalled the HeartMate System Monitor, part of HeartMate LVAS, “due to atypical behavior of the System Monitor screen (screen issues).”
In the case of that recall, “The use of affected product may cause serious adverse health consequences, including decrease in blood pressure and inadequate flow of blood (hemodynamic compromise) caused by a pump stop. This can lead to stroke, irreversible brain damage, heart or organ failure, and death.”
Although there have been 14 reported injuries involving that defective medical device concern, there have fortunately been no reports of death so far.
These medical devices are crucial for sustaining life while awaiting a heart transplant, and in the case of several types of HeartMate heart pumps, have allegedly caused serious injuries and fatalities. Victims of potentially faulty heart pump devices – and their families – may be able to seek compensation for medical expenses, pain, suffering, wrongful death, and more.
Contact Phillips Law Group
If you or a loved one has been injured following the use of a HeartMate heart pump, please consider seeking legal counsel as soon as possible.
There is a critical need for thorough testing and transparent communication of potential risks in medical device manufacturing, and heart pump lawsuits regarding defective or dangerous medical devices could have significant implications for regulatory practices and patient safety standards in the medical device industry. If you or a loved one has been harmed thanks to the use of one of these devices, our team may be able to advocate for you and seek justice on your behalf.
Please call us today at 602-222-2222 for a free, no-obligation consultation to discuss your unique circumstances in a confidential meeting. We can walk you through your next steps and go over what your legal options may be, including a potential HeartMate heart pump claim.
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