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Defective heart pump lawsuits against Abiomed and Abbott claim the following defective medical devices cause injuries and deaths:
Our medical device lawyers are investigating cases where patients suffered injuries or death after receiving one of these products. If you or a loved one received an Impella Left Sided Blood Pump or a HeartMate 2 or Heartmate 3 and sustained injuries, we are here to help.
Contact our office today for a free case evaluation at (800) 277-1193 or complete the Case Evaluation Form.
Our law firm wants to keep you informed about these defective medical devices and the litigation surrounding them.
June 2024
Abbott is recalling a system monitor used with the HeartMate cardiac pump because screen display issues could be dangerous for patients. The Class 1 recall affects 4,842 monitors distributed in the U.S. and worldwide, according to a June 7 entry in the Food and Drug Administration’s database.
May 2024
The US Food and Drug Administration (FDA) has labeled a recall of Abbott’s HeartMate 3 left ventricular assist device (LVAD) as Class I, the most serious type of medical device recall.
This is the second Class I recall for the HeartMate 3 system this year. Earlier, the FDA issued a Class I recall for Abbott’s HeartMate Touch System, which is used to monitor patients with a HeartMate 3 device.
The recall happened because the FDA found problems with the seal between the LVAD inflow cannula and the apical cuff. A broken seal can let blood or air into the device, which can cause bleeding, right heart failure, longer surgeries, or air embolisms.
These seal issues were noticed during the device implantation. The recall for Abbott’s communication systems is a correction, not a product removal, according to an FDA notice.
March 2024
The FDA announced that Abiomed is recalling the Instructions for Use for its Impella Left Sided Blood Pumps because the pump catheter might cut through the wall of the heart’s left ventricle. The FDA classifies the recall as a Class I recall.
The U.S. Food and Drug Administration (FDA) has identified the Impella Left Sided Pump as a Class I recall. This is the most serious type of recall, classified this way because the devices “may cause injuries or death.”
The FDA explains the blood pump’s catheter can perforate the wall of the heart’s left ventricle.
Using the pumps can cause multiple health problems, including:
The New York Times reports the U.S. Food and Drug Administration (FDA) has linked biomed’s Impella Left Sided Blood Pumps to:
According to the article, the FDA told Abiomed it should have notified the agency of the risk that the device can perforate the walls of the heart. The notification should have come at least two years ago. At that time, Abiomed added a brief post about the risks on the company’s website.
According to the FDA, Abiomed blames doctors for injuries related to the device. The company cites “operator handling” as the cause of the problems.
When the FDA investigated Abiomed last year, the agency found Abiomed had not reported many complaints of adverse events. FDA regulations require this reporting. The FDA issued a warning letter to Abiomed in September 2023. This is one of the most serious actions the agency can take.
Many recipients of defective Impella pumps are already in a fragile state. They need interventional treatment to restore normal heart function. However, sometimes the device perforates the wall of the heart or the blood vessels. When this happens, it can require emergency open heart surgery, which has a low survival rate.
Our medical device lawyers are investigating cases in which Abiomed Impella heart pumps fail, causing injury or death.
Abiomed is a cardiovascular medical technology company completely owned by Johnson & Johnson. Johnson & Johnson is one of the largest medical companies in the world. In 2023, the company had approximately $85 billion in revenue.
The defective Abiomed Impella Left Sided Blood Pump underscores the importance of transparent communication and ongoing vigilance in medical device safety. It’s worth comparing the Impella heart pump defect with those of another device.
Surgeons use Abbott’s HeartMate II and HeartMate 3 devices for circulatory support in patients with heart failure. They are considered vital in treating end-stage heart failure.
On April 15, 2024, the FDA issued a Class 1 recall, its most serious, for Abbott’s HeartMate II and HeartMate 3 devices. The recall stemmed from hundreds of injuries and 14 deaths.
Thoratec Corp., a subsidiary of Abbott Laboratories, manufactures the devices.
Abbott/Thoratec Corp. recalled the HeartMate II and HeartMate 3 Left Ventricular Assist System (LVAS) because of an issue called Extrinsic Outflow Graft Obstruction (EOGO).
The problem occurs when biological material builds up between the HeartMate Outflow Graft and the Outflow Graft Bend relief or other components added during surgery.
The buildup obstructs the left ventricular assist device, making it less effective in helping the heart pump blood. This can trigger alarms indicating low blood flow and affect the device’s ability to function properly. The accumulation of biological material typically occurs over two years or more.
Although many law firms might say they can handle your defective heart pump claim, we have the history to prove our abilities. Since 1955, we have been representing people who suffered personal injury or wrongful death at the hands of large corporations.
Our law firm has won over $40 billion in settlements and jury verdicts. Our lawyers have the knowledge and passion to seek justice on your behalf. Most importantly, we charge our clients legal fees only if and when we recover compensation in their cases.
Contact us today for a free, confidential, no-obligation case evaluation at (800) 277-1193 or by completing the Case Evaluation Form.
The FDA has previously announced multiple recalls of the instructions for use for the Impella device. This includes warning that the device may fracture when used on individuals who have had an artificial valve implanted.
Instructions should also warn of the risk of the device increasing the possibility of throwing a clot, which could cause stroke.
Impella heart pump lawsuits could help you recover damages you suffered from the device.
The amount you could get from a settlement or jury verdict depend on the type and severity of your injuries. Possible types of recoverable damages include:
Taking quick action helps ensure the viability of your legal claim. If you or a loved one has been injured following the use of an Abiomed Impella heart pump, promptly seek legal counsel.
When a corporation’s carelessness results in a major injury, consider getting legal representation to support your claim. Their knowledge and proficiency can be quite beneficial when managing challenging legal matters, such as a mass tort.
A lawyer can walk you through the mass tort procedure. They will handle everything so you can focus on your recovery. A mass tort attorney can assist you with your claim in the following ways:
For decades, our lawyers have focused on complex product liability cases, including medical device litigation. We will investigate serious injury or death claims against Abiomed and Abbott.
You might be unsure if the device used in your operation was an Impella device or whether the injury suffered was a perforation.
Our medical device injury lawyers will gather the necessary information from your medical provider to verify the identification of the device and the injury.
Impella Left Sided Blood Pumps are used to support the heart’s pumping chambers (ventricles) for a short time during high-risk procedures called percutaneous coronary interventions (PCI).
Physicians also use these pumps when someone is experiencing cardiogenic shock less than 48 hours after a severe heart attack, open-heart surgery, or due to a condition called cardiomyopathy.
The goal of Impella therapy is to reduce the workload on the heart’s ventricles and support the circulatory system. This gives the heart time to recover.
Different types of Impella pumps are used for various treatments.
Multiple scientific journals have published studies involving individual case reports of perforation of the heart by Impella devices. The earliest published case reports date to 2016, and since then, there have been several other individual case reports.
No studies have compared the risk of perforation with Impella versus other blood pumps, such as traditional balloon pumps. The New York Times says studies show Impella devices may lead to more deaths than balloon pumps.
The FDA has warned doctors about a risk of perforation with Impella devices. Scientists will now study this safety issue more closely in future research.
Our law firm’s investigations focus on legal claims related to injuries resulting from heart perforation due to the Impella device and the HeartMate 2 and Heartmate 3 devices.
If you have been injured or a loved one died as a result of heart perforations during the use of an Abiomed Impella heart pump or complications from an Abbott HeartMate device, you may have legal claims against the manufacturer.
Contact our office today for a free, no-obligation case review at (800) 277-1193 or complete the Case Evaluation Form.
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