Impella Heart Pump Lawsuit

AbioMed Impella Heart Pump Lawsuit Overview

Abiomed Impella Impella Left Sided 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 device 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 now growing evidence that suggests Abiomed knew about the risk of Impella heart tear risks since 2018. However, rather than reporting the Impella heart perforation risks to the FDA in accordance with regulatory requirements, the manufacturer posted 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 Impella heart pump personal injury lawsuits and Impella heart pump wrongful death claims for individuals who have been injured or suffered fatal injuries 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 for an Impella heart pump recall lawsuit, submit information for review by an Impella heart pump lawyer, who will evaluate the circumstances of your potential claim.

Attorneys handle all 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 Updates

• 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 investigating 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 Increased 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.

How Can the Impella Heart Pump Cause Death?

Medical research and FDA recall warnings have indicated the Impella pump can lead 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

In a major regulatory action, 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 updating the 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 use of these Abiomed Impella Heart Pumps may cause serious injuries or death.

August 2023 Impella Recall: Blood Clot Risk

The U.S. Food and Drug Administration (FDA) announced a Class I Abiomed Impella recall on August 17, 2023, indicating that the manufacturer has become aware of at least 12 injuries reported in relation to the catheter system’s instructions and labeling.

The 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) fail 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

Recent research has drawn connections between the use of the Impella device and the emergence of serious and life threatening injuries.

Cardiologists Link Impella Device to Increased Stroke and Death Risk

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 faced an increased risk of;

• 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 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.

Impella Heart Pump Linked to Increased Bleeding Risks

In a study published in the medical journal Resuscitation in May 2023, 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.

While vascular injury differences were not significantly different among users, researchers found 26% of Impella patients experienced serious bleeding complications compared to only 9% of IABP 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 a personal injury lawyer to determine whether a settlement or lawsuit payout may be available.