Impella/Heartmate Devices Mass Torts

Impella and Heartmate devices are vital for supporting patients with severe heart conditions, saving countless lives. However, serious safety and efficacy issues, including heart-wall perforations and wrongful deaths, are creating an urgent need for justice and compensation for affected families.

Heninger Garrison Davis Are Your Trusted Advocates in Mass Torts

Our nationally recognized attorneys specialize in representing individuals impacted by defective medical devices. With over 441 years of combined legal experience and a proven track record of successful verdicts, our expert team is dedicated to holding manufacturers like Abiomed accountable for their negligence. We leverage our extensive resources, in-depth knowledge, and commitment to justice to secure the compensation you deserve. Book a free consultation today and take the first step toward achieving the justice you’re entitled to.

Mass Torts and the Impella Devices

Mass torts are legal actions in which numerous plaintiffs are harmed by the same defendant’s wrongful conduct. They typically involve defective products, environmental disasters, or large-scale negligence.

Unlike individual lawsuits, mass torts consolidate similar claims to streamline the legal process, making it more efficient and effective for all parties involved. This collective approach allows for shared resources, unified strategies, and stronger bargaining power against powerful defendants.

Due to their widespread use and the significant number of adverse incidents reported, Impella devices fall under the umbrella of mass torts.

What is the Impella Lawsuit About?

The Abiomed Impella Blood Pumps are designed to provide temporary assistance to the heart’s ventricles during open-heart surgery or after a severe heart attack. Despite their intended benefits, the FDA has issued several recalls due to serious adverse health consequences. As of mid-2024, at least 129 serious injuries and 49 deaths have been linked to Impella heart pumps.

Evidence suggests that Abiomed may have been aware of these risks but failed to adequately report them to the FDA, instead categorizing them as “rare complications” in technical bulletins. This lack of transparency has led to numerous injuries and fatalities, prompting nationwide legal reviews and potential lawsuits.

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Recent Investigation Updates

January 21, 2025

The first known Impella heart pump wrongful death lawsuit filed in St. Louis alleges that a defective Impella 5.5 device caused intravascular hemolysis, contributing to a patient’s death.

October 1, 2024

Lawyers are actively investigating dozens of claims for severe or fatal injuries related to Impella pumps.

August 14, 2024

FDA issued a recall for nine defective Impella units from a single lot, linked to severe cardiovascular issues and potential deaths.

May 6, 2024

A study in The New England Journal of Medicine highlights increased risks of bleeding, limb damage, hemolysis, device failure, and higher mortality rates with Impella use.

March 21, 2024

FDA announced a recall for the Impella Left Sided Blood Pump after reports of pump catheter perforations leading to over 100 injuries and nearly 50 deaths.

How Can the Impella Heart Pump Cause Death?

Numerous studies have raised safety concerns. For example:

2019 AHA Study: Found higher rates of bleeding, kidney problems, stroke, and death among Impella users compared to intra-aortic balloon pump (IABP) users.
2013 Resuscitation Journal Study: Identified significantly higher rates of serious bleeding events and lower survival rates among Impella users compared to IABP users.

These studies indicate that the Impella pump has been linked to severe complications and fatalities due to:

Heart Wall Perforation: Mechanical damage can breach the heart muscle, causing severe internal bleeding.
Hemodynamic Instability: Severe fluctuations in blood pressure and circulation can lead to shock and inadequate organ perfusion.
Cardiac Tamponade: Blood accumulation around the heart can compress it, hindering its pumping function.
Organ Failure: Prolonged insufficient blood flow can result in the breakdown of multiple organ systems, often fatal.

Are There Any Abiomed Recalls?

Several Class I recalls have been issued for various Impella models; specifically:

March 2024

Impella Left Sided Blood Pump recall for heart perforation risks involving approximately 66,390 models.

August 2023

Impella recall for blood clot risks due to inadequate safety precautions in labeling.

July 2023

Impella pump failure and fragment release risk, particularly for patients with TAVR stents, affecting 30 complaints, including 26 injuries and four deaths.

What Compensation Can I Pursue?

Financial compensation may be available through settlement or lawsuit payout for those who experienced any of the following complications:

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

Types of potential compensation include the following:

Medical Expenses: Covering past and future medical costs related to Impella-induced injuries.
Lost Wages and Earning Capacity: Compensation for lost income and diminished future earning potential.
Pain and Suffering: Reimbursement for physical pain, emotional distress, and overall suffering.
Wrongful Death: Financial support for families who lost a loved one due to defective Impella devices, covering medical bills, funeral expenses, and loss of companionship.

Compassionate. Experienced. Results-Driven. Heninger Garrison Davis is Leading the Charge in Mass Torts.

At Heninger Garrison Davis (HGD), our expertise in mass tort litigation uniquely positions us to handle the complexities of Impella and Heartmate device cases. Our dedicated team works tirelessly to:

Identify and consolidate claims, recognizing the commonalities among affected individuals to build a unified and compelling case
Leverage our extensive resources to investigate, document, and present each case with precision and authority
Ensure that every plaintiff receives the compensation and accountability they deserve, holding Abiomed responsible for their negligence

Joining a mass tort action can significantly enhance your pursuit of justice. Contact Heninger Garrison Davis today to learn how we can support your case and help you achieve justice.

Impella/Heartmate Devices Mass Torts FAQ

How Do I Know If I'm Eligible to Join the Impella Mass Tort Case?

You or your loved one must meet the following criteria:

You or your loved one must have been implanted with an Impella or Heartmate device
There must be a direct link between the device and the injury or death suffered
The device was used within the timeframe when the known defects or issues were present
You have adequate medical records and evidence to support your claim

What is the Timeline for an Impella Mass Tort Case?

On average, mass tort cases can take one to three years to resolve, but this can vary significantly based on the specifics of each case.

What is the Difference Between a Class Action and a Mass Tort?

A class action is a single lawsuit that represents all plaintiffs. All members have identical or very similar claims, and a single judgment or settlement applies to all members. In mass torts, each plaintiff may file separate lawsuits that are coordinated and can have unique circumstances and damages. Cases are managed collectively to streamline processes but allow for individual considerations. Mass torts, like the Impella case, often provide more flexibility and personalized attention compared to class actions.

How Long Do I Have to File a Lawsuit for Impella Device Injuries?

The time you have to file a lawsuit, known as the statute of limitations, varies by state and the nature of the claim. Personal injury claims typically range from 1 to 3 years from the date of injury.

Can Family Members of a Deceased Patient File a Lawsuit?

Yes, family members of a deceased patient can file a wrongful death lawsuit if the death was caused by complications from an Impella device. HGD's experienced attorneys can guide you through the process of filing a wrongful death claim to ensure justice for your family.

What If My Impella Device Was Recalled After My Procedure?

If your Impella device was recalled after your procedure and caused injury or complications, you may still be eligible for compensation. Recalls strengthen your case by showing that the device was acknowledged as defective by the manufacturer or regulators.

What Happens If My Case Does Not Settle?

If your case does not settle, it may proceed to trial. While settlements are more common in mass torts due to their efficiency, HGD is fully prepared to take your case to trial if necessary to secure justice. Our extensive experience ensures that your interests are effectively represented in court.