Impella Heart Pump Lawsuit

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Legal Action Now Being Taken Against Impella Heart Pump Maker

With advances in medical technology, new methods for promoting awareness, and general emphasis on the importance of overall health, one could reasonably expect that heart disease is no longer the threat it once was. Sadly, that isn’t the case.

According to the Centers for Disease Control (“CDC”), heart disease is still the leading cause of death for most Americans. Statistics cited by the agency indicate that 17.4% of deaths of people across all ethnic groups in 2021 were attributed to heart disease.  

But that’s not all. The American Heart Association (“AHA”) published an update and fact sheet containing more recent information this year. In it, the organization noted that cardiovascular disease (CVD), identified as the underlying cause of death, accounted for more than 941,00 deaths in the United States in 2022. Of the total number of deaths attributed to CVD in the United States that year, coronary heart disease (CHD) caused 371 506, the AHA reported. In other words, coronary heart disease (CHD) was the leading cause of deaths (39.5%) attributable to CVD in the United States in 2022.

Fortunately, not all heart disease leads to immediate death. Instead, there are certain medicines and tools that doctors can use to help people with different diagnoses. One of these devices is the Impella Heart Pump, which can be used as medical support for people experiencing certain conditions. These include but are not limited to some complications following heart attacks, and heart failure.

Unfortunately, Impella Heart Pumps have recently been linked to serious heart injuries. This in turn has resulted in multiple lawsuits. If you or a relative suffered serious complications while using an Impella Heart Pump, or if a loved one died while using an Impella Heart Pump, Van Law Firm may be able to help.

A Brief Overview of the Impella Heart Pump

An Impella Heart Pump is a small pump that is used to help the lower chambers of the heart, or ventricles, function. More specifically, it acts as a substitute for the left ventricle by pumping blood out of the heart and to the rest of the body. 

By doing so, the pump gives the left ventricle time to recover in patients suffering from a condition called cardiogenic shock. It also facilitates sufficient blood flow when the heart is not working properly, and the protection of the heart and organs during some medical procedures.

Experts say the additional benefits of Impella Heart Pumps are that they can be inserted without surgery and that they can transmit information to an external console. Healthcare providers can then use the information to assess heart function and how much blood the device is pumping.

However, experts also note that Impella Heart Pumps are not meant for use outside of hospital settings. This means they are not long-term solutions for most patients.

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Who Makes Impella Heart Pumps?

Known for providing heart, lung and kidney support technologies globally,  Abiomed is the U.S. medical device company responsible for making Impella Heart Pumps. 

Its products include the:

• Impella 2.5
• Impella CP
• Impella CP with SmartAssist
• Impella 5.0
• Impella LD
• Impella 5.5 with Smart Assist
• Impella RP
• Impella RP Flex
• Impella RP Flex with SmartAssist

The company’s history dates to 1981, when it was founded for the purpose of developing the artificial heart. The FDA approved Abiomed’s first ventricular assist device in 1992 and Abiomed marked another significant milestone with its acquisition of  Impella Cardio Systems in Aachen, Germany in 2005. A series of FDA approvals for various Impella Heart Pumps followed.

Abiomed is now owned by Johnson & Johnson, which acquired it for more than $16 billion in 2022.

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A Troubling Track Record

In recent years, Abiomed’s Impella Heart Pumps have reportedly been the subject of several  U.S. Food and Drug Administration (FDA)  recalls. 

These recalls purportedly included warnings that the pumps in question may cause serious injuries, such as: 

• heart perforations
• hypertension 
• insufficient blood flow or absence of blood flow
• death

By the middle of last year (2024) the FDA had noted numerous “adverse events” linked to Impella Hearth Pumps. These included at least 129 serious injuries and 49 deaths. 

In an early Impella Heart Pump lawsuit, the family of a woman who died a few days after open heart surgery that included the use of one Abiomed’s heart pumps accused the company of negligence, defective design, and failure to warn about risks. 

Specifically, the lawsuit alleged that the device caused intravascular hemolysis (breakdown of red blood cells), and that this in turn impeded blood flow, ultimately leading to the patient’s death. The lawsuit also alleged that the device was defective due to a manufacturing flaw  in the pump’s lead release. Plaintiffs reportedly sought compensation for financial losses, emotional suffering, and funeral expenses.

Abiomed has repeatedly requested that this particular case be dismissed, however.

Qualifying For An Impella Heart Pump Case

You may be able to file a wrongful death suit if a loved one died following the insertion of an Impella Hearth Pump. You may also be able to pursue legal recourse if you or a loved one experienced a serious injury following insertion of one of the devices. Examples of serious injuries include: 

• heart tear/perforation 
• stroke 
• organ failure
• anemia
• blood clots
• prolapsed valve
• vascular damage
• hemolysis (Red blood cell destruction)
• other serious injury/injuries

Don’t leave anything to chance. Call Van Law Firm to schedule a comprehensive assessment of your Impella Heart Pump injury or wrongful death claim today.