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Texas Impella Heart Pump Lawsuit (2024 Latest Updates)

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C.L. Mike Schmidt Published by C.L. Mike Schmidt

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Quick Summary

  • If you’re looking into the Texas Impella heart pump lawsuit, as a patient, a loved one, or a healthcare professional, it’s crucial to know your rights.
  • This article dives into the details of the ongoing lawsuits, offering clear guidance on eligibility for filing a claim and how to seek legal assistance.
  • If you or someone you know has been affected by the Impella heart pump, Schmidt & Clark, LLP, a leading law firm, is here to provide comprehensive legal assistance. Renowned for our proficiency in plaintiff representation, our main objective is to ensure you obtain the justice and compensation you rightfully deserve.

How S&C Can Help With Your Claim?

S&C can help with your claim by providing expert legal services in the healthcare and life sciences sector. With a reputation for excellence in representing clients involved with heart support technologies, including the Impella heart pump, our multidisciplinary team is adept at navigating complex legal challenges that span intellectual property and antitrust matters.

S&C is well-equipped to support Impella heart pump injury claims thanks to our:

  • Proven expertise in medical technology litigation
  • Prior experience with Abiomed, the Impella heart pump manufacturer
  • Comprehensive legal knowledge that provides a strategic advantage to clients

Impella Heart Pump Lawsuit

The Impella Heart Pump lawsuit arises from the shocking fact that impella heart pumps recalled amount to more than 66,000 devices, which have been linked to increased risks leading to severe medical complications and deaths.

According to the FDAs 2023 notice, the affected Impella pumps are part of a recall due to the risk of the pump catheter cutting or perforating the wall of the left ventricle of the heart during operations, leading to catastrophic bleeding, death, and other serious adverse health consequences [1].

There have been 129 reported serious injuries in the United States linked to the device and 49 deaths in the United States linked to the device.

The sheer scale of the recall and the number of reported injuries and deaths underscore the gravity of the issue.

The FDA’s issuance of a Class I recall, their most severe classification, further highlights the potential risks associated with the use of the Impella Heart Pump devices, indicating that the device use could cause serious injuries or death. In the face of such alarming revelations, it’s crucial to understand the device, its function, and the complications it can cause.

What Is an Impella Heart Pump?

An Impella heart pump is a small device designed to support the function of the heart’s ventricles, particularly the left ventricle, which is responsible for pumping blood out of the heart to the rest of the body.

It’s classified as a percutaneous ventricular assist device (VAD). It is commonly used during percutaneous coronary interventions (PCI) and in the management of cardiogenic shock, providing essential support during these high-risk procedures and ensuring the heart pumps blood efficiently.

The significant advantage of the Impella device is that it can be inserted through a small incision in the leg to access the femoral artery and then threaded into the left ventricle, eliminating the need for open-heart surgery.

This makes it an invaluable tool in hospital settings, often serving as a bridge for patients recovering from a cardiovascular event or awaiting more permanent interventions like a heart transplant.

The Impella Left Sided Blood Pumps work by temporarily assisting the heart’s ventricles in pumping blood during high-risk medical procedures, thereby supporting the circulatory system.

The Impella CP heart pump, in particular, is leveraged for its supportive role during surgical interventions or for the management of severe heart conditions such as cardiomyopathy.

The device is strategically placed within major blood vessels to help maintain blood flow and reduce the workload on the heart during critical medical situations such as heart attacks or the treatment of cardiomyopathy.

This seemingly beneficial mechanism of action, however, has been stained by an alarming number of complications, including:

  • Device migration
  • Device fracture
  • Infection
  • Thrombosis
  • Hemorrhage
  • Vascular injury

These complications have raised concerns about the safety and effectiveness of the device.

Reasons Behind The Recall: Serious Adverse Health Consequences

According to the Society of Thoracic Surgeons, complications related to the Impella CP left-sided heart pump are serious and life-threatening, with 49 deaths and 129 injuries linked to heart wall tears alone [2].

Certain demographics, including older adults, women, and patients with anterior infarction, are at a higher risk of experiencing these grave complications. Patients with pre-existing conditions, particularly those who have suffered a major heart attack, are also vulnerable to the risk of heart-wall tears caused by the device.

The situation becomes even more concerning when you learn that the FDA found that Abiomed did not report the issue of heart wall tearing, classified as a ‘rare complication,’ in a bulletin dating back to January 2018. The recalled devices also carry risks of blood clots, particle deposits, and the potential for puncturing delicate heart tissue.

The recall encompasses various models of the Impella pump, including:

  • Impella 2.5
  • Impella CP
  • Impella 5.5
  • Impella RP Flex with SmartAssist Heart Pumps
  • Impella 5.5 with SmartAssist

These Impella heart pumps were distributed between October 10, 2021, and October 10, 2023, marking a two-year span during which thousands of patients may have been exposed to the device’s potential risks. Given the severity of the device’s potential side effects, it’s vital to understand what they might entail.

Side Effects of Impella Heart Pump in Acute Heart Failure

The side effects associated with Impella Heart Pumps are severe and potentially life-threatening. Reports indicate that 129 serious injuries and 49 deaths are linked to the use of these devices. The recalled pumps might cause left ventricle perforation or free wall rupture, both of which are life-threatening injuries.

Such injuries can lead to severe health consequences such as:

  • a lack of blood flow
  • hypertension
  • decreased blood flow
  • death

Ultimately, these serious adverse health consequences can result in decreased blood flow and death. Given these potential side effects and the scale of the recall, it’s crucial to understand who might qualify for a lawsuit.

Stroke is one of the most common and serious complications of many MCSs, and Impella is no exception – Shunsuke Saito (M.D., PhD), Cardiovascular Surgeon at the Department of Cardiovascular Surgery, Osaka University

How Do You Qualify for an Impella Heart Pump Lawsuit?

To qualify for an Impella Heart Pump lawsuit, you must be an individual or a representative of an individual who had the device implanted between October 10, 2021, and October 10, 2023. This period is important to note due to the extensive distribution of the devices during these dates.

Additionally, patients who have experienced severe complications, such as the Impella heart pump catheter cutting or puncturing the heart during implantation, may qualify to file a lawsuit. Given the gravity of these complications, it’s crucial to stay informed about the status of the ongoing litigation.

The Status Of The Impella Heart Pump Lawsuit Litigation in Texas

In Texas, the Impella Heart Pump litigation has been actively monitored. Recent case studies have revealed a growing interest in specific instances where Texas patients suffered acute heart failure attributed to the use of the Impella heart pump.

These cases not only highlight the severe complications associated with the device but also provide insight into the legal landscape surrounding the Impella Heart Pump lawsuits.

Impella Heart Pump Lawsuit Settlement Amounts in Texas

Settlement amounts in Texas Impella lawsuits vary, with compensation reflecting the severity of sustained injuries. The District Court in Texas has seen a range of rulings in Impella heart pump lawsuits, some resulting in favor of the plaintiffs due to established device malfunctions.

Several high-value settlements have been awarded to plaintiffs in the Texas Impella lawsuits, reinforcing the potential for substantial financial compensation for those affected by the device. However, filing a lawsuit involves gathering specific evidence within a defined timeframe, making it crucial to understand the process.

Filing an Impella Heart Pump Lawsuit in Texas

Filing an Impella Heart Pump lawsuit in Texas involves several key steps. First and foremost, potential plaintiffs must gather the necessary evidence, which can range from medical records and diagnostic test results to expert witness reports and medical bills. Additionally, it’s essential to understand the specific timeframe, or the statute of limitations, within which a lawsuit must be filed.

Types of Evidence To Present

Various types of evidence can strengthen a lawsuit, including:

  • Medical records documenting the use of the Impella Heart Pump and the subsequent complications
  • Hospital Policies
  • Healthcare regulations
  • Diagnostic test results

These sources of evidence can further bolster a case.

Expert witness reports are also crucial in establishing the standard of care and demonstrating whether there has been a deviation from that standard. Witness statements and video evidence can supplement these types of evidence, providing a comprehensive overview of the events surrounding the use of the Impella Heart Pump.

What is the Statute of Limitations for the Impella Heart Pump Lawsuit in Texas?

The statute of limitations for the Impella Heart Pump lawsuit in Texas is typically two years from the date of injury. Still, individuals should consult with an attorney to confirm the specific deadline applicable to their case, as there may be exceptions or extensions under certain circumstances.

The FDA’s issuance of a Class I recall for the Abiomed Impella Heart Pump Device instructions could be pertinent to the statute of limitations timeframe for a lawsuit. You may be eligible to file a lawsuit if you or your next of kin had an Impella Heart Pump Device implanted between October 10, 2021, and October 10, 2023.

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Schmidt & Clark, LLP stands with you in these trying times. Should you or someone close to you experience complications from the Impella heart pump, we encourage you to get in touch with us.

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