Patients suffering from end-stage left ventricular heart failure may have been injured by a defective medical device. The defects in the medical device have been linked to fatalities.
A well-known medical device used in patients with heart failure has been recently recalled by Abbott Laboratories, the manufacturer of the HeartMate 3™ Left Ventricular Assist System. Based on information provided by the Food and Drug Administration (FDA), Abbott Laboratories have recently issued notices to physicians about a potentially life-threatening defect linked with the HeartMate 3™ device. Upon knowledge of the defect, Abbott did not immediately recall the product but rather provided physicians with a set of guidelines for monitoring the issue with their patients (these guidelines are available on the FDA’s recall notice).
However, after there have been many patient deaths associated with the HeartMate 3™ pump, the medical device company finally decided to go forward with distributing a recall of the device. Therefore, the HeartMate 3™ is now subject to a class I recall, which means that a product is dangerous enough to cause serious injuries or potentially death to patients. The FDA declares class I recalls are the most serious type of recall presented.
About the Abbott HeartMate 3™ Left Ventricular Assist System
The HeartMate 3™ Left Ventricular Assist System, manufactured by Abbott Laboratories, is a device that helps deliver blood from an individual’s heart to the rest of their body. The HeartMate helps damaged hearts pump blood more effectively, and is used for patients with severe left ventricular heart failure. Ultimately, the device is intended to be used on a short-term basis for patients who are at risk of death for “end-stage left ventricular heart failure.” Patients such as these are typically on a waiting list to receive a heart transplant. The HeartMate 3™ includes a blood pump that is implanted into the space around the area of the heart known as the “pericardium.” The system also includes an “outflow graft” that connects the pump to the aorta.
Reason for Abbott HeartMate 3™ Left Ventricular Assist System Recall
Abbott is recalling the HeartMate 3™ Left Ventricular Assist System due to a discovery of a malfunction in the device’s outflow assembly that may cause the outflow graft to twist and close up (occlusion) over time. Twisting of the outflow graft can occur at any point after implant. If there is an occlusion, the outflow graft can reduce or stop pump flow and set off a persistent “low flow” alarm in the system that goes off if there is an insufficient level of blood flow. A reduction in pump can lead to serious adverse events such as blood clots and death.
The FDA has provided the following recall information for the HeartMate 3™ Left Ventricular Assist System that is subject to a class I recall:
- Product Name: HeartMate 3™ Left Ventricular Assist System
- Model Number (for the United States): Catalog # 106524US
- Lot Numbers: All
- Manufacturing Dates: All
- Distribution Dates: September 2, 2014 to Present
- Total Number of Devices Recalled in the United States: 4,878
How does the Abbott HeartMate 3™ LVA Cause These Problems?
The failures may stem from possible interruptions in the electrical connection between power sources, including batteries, adapters and the HVAD controller, which could cause disconnection and result in possible pump stoppage.
The outflow assembly is not designed to twist or close up, and because of the recently identified defect in the HeartMate 3™ device where such twisting and occlusion was present, patients with this device are at risk of suffering severe injuries or death.
How We Can Help
Our attorneys are currently evaluating and investigating claims on behalf of patients who have suffered serious side effects as a result of using the Abbott HeartMate 3 Left Ventricular Assist System. If you have been diagnosed with any of the serious conditions listed above after using the Abbott Heartmate 3 LVA, please contact us immediately.
In many cases, filing a lawsuit is the only way to recover money that is lost from hospital expenses, lost wages, and for some the grief and financial losses caused by a loved one’s death. Others file lawsuits because they want to make a difference and prevent others from suffering through the same preventable harm as they have. Van Wey, Presby & Williams Law Can Help, No Matter Where You Live. To discuss the specifics of your potential lawsuit in a free and confidential consultation, contact us today. You may call us at 1(888)-694-8093.