Impella Heart Pump Lawsuit

AbioMed Impella Heart Pump Lawsuit Overview

The Abiomed Impella Blood Pumps are medical devices designed to provide temporary assistance to the heart’s ventricles, and to support patients through open heart surgery or in the aftermath of a severe heart attack. The primary function of the Impella pump is to lighten the heart’s workload and provide support for the circulatory system.

While intended to assist the heart’s ventricles, the U.S. Food and Drug Administration (FDA) has issued several Impella heart pump recalls in recent years warning that the affected Impella pumps may cause serious adverse health consequences, including left ventricle perforation or free wall rupture, hypertension, lack of blood flow, and death. These problems have resulted in FDA adverse events involving at least 129 serious injuries and 49 deaths from Impella heart pumps as of mid-2024.

There is also growing evidence that suggests Abiomed knew or should have known about the Impella heart tear risks for years. However, rather than reporting the Impella heart perforation problems to the FDA in accordance with regulatory requirements, it appears that the manufacturer elected to post a technical bulletin on its website categorizing the events as a “rare complication”.

As a result of the growing number of injuries and deaths linked to the Impella heart pumps, lawyers across the nation are reviewing potential Impella heart pump lawsuits and wrongful death lawsuits for individuals who have been injured or suffered fatal complications that may have been caused by the medical devices.

Who Qualifies for an Impella Heart Pump Lawsuit?

Financial compensation may be available through an Impella heart pump lawsuit for individuals who experienced any of the following complications after receiving an implantable Impella heart pump:

• Heart tear/perforation
• Stroke
• Organ failure
• Wrongful death
• Anemia
• Blood clots
• Hypertension
• Bleeding events
• Prolapsed valve
• Vascular damage
• Reduced blood flow
• Hemolysis (Red blood cell destruction)
• Other serious injury

To determine if you or a loved one qualify to pursue a potential Impella heart pump recall lawsuit, submit information for review by a product liability lawyer, who will evaluate the circumstances of your potential claim and determine whether a claim can be pursued.

Lawyers handle all potential Impella heart pump lawsuits on a contingency fee basis, which means that there are no fees or expenses paid unless a settlement or lawsuit payout is received.

2024 Impella Heart Pump Lawsuit Investigation Updates

• October 1, 2024 Update: While no Impella heart pump lawsuits have yet been filed against Abiomed, a number of product liability lawyers are actively investigating dozens of claims for individuals who experienced severe or fatal injuries that may have been avoided.
• August 14, 2024 Update: The U.S. Food and Drug Administration (FDA) issued an Impella Heart Pump recall on August 12, 2024, after identifying that nine defective units from a single lot had been accidentally distributed by manufacturer AbioMed. These devices pose serious risks, potentially releasing harmful particulates or failing suddenly, leading to severe cardiovascular issues including stroke, low blood pressure, and heart attack, or even necessitating additional surgeries and possibly resulting in death.
• May 6, 2024 Update: A recent study in The New England Journal of Medicine highlights significant findings about the Impella heart pump. While it reduces fatalities by 13% in certain cardiogenic shock patients, the Impella device is linked to severe bleeding and limb damage, as well as hemolysis, device failure, and worsening aortic regurgitation. The study also noted that 41.9% of the Impella group required renal replacement compared to 26.7% for the standard care group.
• April 10, 2024: Due to the growing number of FDA recalls and medical research linking Impella Heart Pumps to serious injuries and fatalities, lawyers are evaluating potential Impella Heart Pump wrongful death lawsuits and personal injury claims for those who received a recalled Impella Pump.
• March 21, 2024: The U.S. Food and Drug Administration announced the Impella Left Sided Blood Pump recall correction on March 21, following numerous reports of the pump catheters piercing the wall of the left ventricle in the heart, which have been linked to more than 100 injuries and nearly 50 deaths.

Impella Heart Pump Linked to Higher Fatality Rates

The Impella Heart Pump has been linked to a series of problems outlined in FDA warnings and recalls in recent years, with one of the first and most notable warnings issued in May 2019, when the FDA highlighted an increased mortality rate with Abiomed Impella RP Heart Pumps.

In the clinical trials relied on to approve the device, 44 out of 60 patients, or 73.3 percent, survived up to 30 days following use of the device. However, real-world results from a 2019 post-approval study (PAS) showed only a 28% survival rate among Impella patients transitioning to long-term therapy.

The warning indicated that only 12 out of 42 patients enrolled in a post-approval study survived to the 30-day hospital discharge mark. While the FDA did note that differences in patient health before receiving the device could account for some of the observed differences in outcomes, the findings raised serious safety concerns.

How Can the Impella Heart Pump Cause Death?

Medical research and FDA recall warnings indicate that the Impella pump has been linked linked to severe complications and even death due to:

• Heart Wall Perforation: Mechanical damage from the pump can breach the heart muscle, potentially causing severe internal bleeding.
• Hemodynamic Instability: Fluctuations in the patient’s blood pressure and overall circulation may become severe, potentially leading to a shock state and inadequate organ perfusion.
• Cardiac Tamponade: Blood accumulation around the heart due to internal bleeding can compress the heart, severely hindering its pumping function.
• Organ Failure: Insufficient blood flow over an extended period can lead to the breakdown of multiple organ systems, often leading to fatal outcomes.

Abiomed Impella Heart Pump Recalls

Following the early warnings about Impella mortality rates, a number of Class I Impella heart pump recalls have been issued in recent years due to a variety of problems. The Impella pumps that have been subject to FDA recalls and instruction for use updates include:

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

March 2024 Impella Recall: Heart Perforation Risk

The FDA announced a Class I recall for the Impella Left Sided Blood Pump on March 21, 2024, following numerous reports of the pump catheter piercing the wall of the left ventricle in the heart, which may cause serious and life-threatening health effects.

Officials indicated the manufacturer was aware of at least 129 reports of serious injuries, including 49 reports of death from Impella pump heart perforations.

The recall included approximately 66,390 models of the device, including;

• Impella 2.5
• Impella CP
• Impella CP with SmartAssist
• Impella 5.0
• Impella 5.5 with SmartAssist
• Impella LD

In response to the problems, Abiomed initially issued updated instructions for use and added additional warnings to address the risk of the catheter causing a tear in the heart’s left ventricle wall on December 27, 2023. However, the FDA classified the actions as a Class I recall, indicating that the continued use of these Abiomed Impella Heart Pumps poses a risk of serious injuries or death.

August 2023 Impella Recall: Blood Clot Risk

An earlier Class I Abiomed Impella recall was announced by the FDA on August 17, 2023, indicating that the manufacturer had become aware of at least 12 injuries reported in relation to the catheter system’s instructions and labeling.

That recall stated the instruction labels provided with the catheter systems do not provide proper safety precautions or actions health care providers should take if their patient’s anticoagulation clotting rate is below the recommended level.

Officials indicated the Impella warning labels also fail to indicate the risks of developing blood clots or deposit formations associated with use of the catheters, increasing the risk of:

• Formation of particle deposits
• Blood clots
• Death

July 2023 Impella Recall: Pump Failure and Fragment Release

The FDA announced a Class I medical device recall for several Impella heart pump models on July 27, 2023, due to insufficient instructions for clinicians treating patients with transcatheter aortic valve replacement (TAVR) stents. The current Instructions for Use (IFU) failed to provide adequate precautionary measures or management strategies for using Impella devices in patients who have undergone TAVR, including the absence of information on potential complications arising from the interaction between Impella devices and TAVR.

Officials warned there is a risk that the Impella’s motor housing could make contact with a TAVR’s distal stent, potentially damaging or completely destroying the motor’s impeller blades, resulting in

• Fragments released into patient’s bloodstream
• Decreased blood flow
• Complete halt of the pump
• Delay therapy

At the time of the recall, Abiomed had become aware of 30 complaints related to the issue, including 26 injuries, and four deaths.

Studies Linking Impella To Dangerous Side Effects

A number of studies have been published in prior years that raised serious concerns about the risk of potential Impella pump complications, leading to questions about why the manufacturers failed to take steps to ensure patients and the medical community were adequately warned about the risk of serious and life threatening injuries linked to Impella devices.

Cardiologists Link Impella Device to Increased Rates of Stroke and Death

In a study published by the The American Heart Association (AHA) in November 2019, cardiologists at Washington University School of Medicine found that individuals undergoing percutaneous coronary interventions (PCI) that received an Impella device had higher rates of serious adverse events and medical costs, including:

• Bleeding events,
• Kidney problems,
• Stroke and
• Death.

The researchers analyzed information from the Premier Healthcare Database, encompassing data involving 48,000 individuals cared for in 432 hospitals across the US. Slightly less than 10% of these patients were treated with an Impella pump, whereas the other 90% were given an intra-aortic balloon pump.

The findings indicated that the Impella pump came with a 24% greater odds ratio risk of mortality compared to the balloon pump, along with a 34% higher chance of stroke. The study found no area in which the Impella pump offered better results, but the researchers noted that the observational study can not prove causation and called for further research to fully understand the risks associated with the Impella pump.

Medical device manufacturers have an obligation to adequately research and investigate potential risks associated with their products, and disclose information necessary to allow doctors and patients to make informed treatment decisions.

Impella Heart Pump Linked to Bleeding Problems

Years earlier, in a study published in the medical journal Resuscitation in May 2013, researchers identified significantly higher rates of serious bleeding events among Impella users compared to those using an intra aortic balloon pump (IABP).

Researchers reviewed 78 post-cardiac arrest patients who were assisted by either an Impella medical device (35) or an IABP (43). According to the findings, the survival rate was 23% for Impella users compared to nearly 30% for IABP users.

The report indicated that vascular complications were not significantly different among participants, but researchers found 26% of Impella patients experienced serious bleeding complications compared to only 9% of IABP patients.

While other studies have been published that offer additional insights regarding potential advantages and risks associated with Impella pumps, there remain serious questions about whether the manufacturer ignored important safety signals and placed a desire for profits before the health and safety of patients.

Impella Heart Pump Lawsuit Settlement Benefits

If you or a loved one has suffered due to the malfunctioning or improper handling of an Impella heart pump, you may be entitled to compensation for;

Medical Expenses: You may be entitled to compensation for past and future medical expenses related to the injuries caused by the Impella device. This includes hospital stays, surgeries, medications, and any ongoing medical treatments or rehabilitation.

Lost Wages and Earning Capacity: If the injuries have impacted your ability to work, a lawsuit may recover lost wages. Additionally, if the injuries affect your future earning capacity, compensation can include projected future losses.

Pain and Suffering: Beyond the financial impact, compensation can be sought for physical pain, emotional distress, and suffering due to the injuries or the loss of a loved one.

Wrongful Death: Filing a lawsuit is the first step in holding the manufacturer accountable for the loss of your loved one, while also securing financial compensation to alleviate the economic strain that often accompanies such a loss.

By filing an Impella wrongful death lawsuit, you may be able to obtain compensation for;

• The emotional pain and suffering endured by you and your family.
• The medical bills, funeral expenses, and burial costs incurred due to your loved one’s passing.
• The profound loss of companionship, consortium, as well as the economic support and household contributions previously provided by your loved one.

Have an Impella Lawyer Review Your Case

Impella Heart Pump lawyers are providing free consultations and claim evaluations for individuals who have suffered injuries caused by an Impella pump. There are no fees or expenses unless a recovery is obtained in your case.

How to file an Impella Heart Pump Lawsuit?

If you or a loved one were injured by an Impella pump device, submit information about your potential claim for review by an Impella personal injury lawyer to determine whether a settlement or lawsuit payout may be available.