Pennsylvania Impella Heart Pump Lawsuit: Risks and Recalls in 2024

Impella Heart Pump Lawsuit Overview

The Impella heart pump lawsuits involve allegations that these medical devices caused severe injuries and deaths in patients.

Plaintiffs claim that Abiomed, the manufacturer, failed to adequately warn about serious complications associated with the device.

Over 66,000 Impella blood pump devices were recalled across the United States. The FDA has classified this recall as Class I, indicating a high risk of serious injury or death [1].

Latest Impella Heart Pump Lawsuit Updates

• March 15, 2025 – The Pennsylvania litigation has consolidated several Impella heart pump lawsuits into a mass tort proceeding. The court is currently managing the pre-trial process, including discovery and motions that will shape the direction of the lawsuits.
• February 2, 2025 – Recent developments have seen the consolidation of several MDL-ready depositions against Abiomed. The legal strategy of plaintiffs has gained momentum as more cases continue to be filed.
• January 10, 2025 – The Pennsylvania litigation has moved forward with settlements being negotiated for victims. Plaintiffs who have suffered wrongful death and personal injury due to Impella device failures are seeing increased settlement offers.
• December 5, 2024 – Abiomed has been ordered by Pennsylvania courts to produce internal documents relating to the design and testing of the Impella heart pump devices.
• October 20, 2024 – The FDA initiated a Class I recall of all Impella Heart Pump devices distributed between October 10, 2020, and October 13, 2023, after serious injuries and fatalities linked to the pumps.

FDA Reports and Statistics

According to the FDA’s MAUDE database, there have been over 4,500 adverse event reports related to Impella heart pump devices. These reports include:

• 252 deaths directly attributed to device malfunction
• 1,875 cases of serious cardiac complications
• 605 cases of blood clots and thrombosis
• 783 cases requiring emergency device removal

The FDA’s classification of the recall as Class I indicates a high risk of serious injury or death associated with these pumps. Over 66,000 Impella blood pump devices were recalled across the United States, marking a significant chapter in the saga of this heart pump.

Impella Heart Pump Injuries & Side Effects

Patients using the Impella heart pump have reported numerous severe complications and side effects following device implantation.

• Hemolysis and Hemolytic Anemia: Destruction of red blood cells leading to serious blood abnormalities
• Thrombosis and Embolism: Formation of dangerous blood clots that can cause stroke or organ damage
• Vascular Complications: Damage to blood vessels, including perforation and bleeding
• Device Migration: Movement of the device from its intended position, causing organ damage
• Infection and Sepsis: Severe infections that can lead to life-threatening septic shock
• Heart Failure Exacerbation: Worsening of the very condition the device was meant to treat
• Wrongful Death: Fatal complications resulting from device failure or complications

Do You Qualify for an Impella Heart Pump Lawsuit?

You may qualify for an Impella Heart Pump lawsuit if:

• You received an Impella heart pump device between 2020 and 2023
• You experienced serious side effects including hemolysis, thrombosis, vascular complications, device migration, infection, or worsening heart failure
• The injuries required medical treatment or hospitalization
• You have suffered personal injury and emotional distress as a result
• A loved one died following complications from an Impella heart pump (wrongful death claim)
• You can provide medical documentation linking your injuries to the Impella device

Evidence Required for an Impella Heart Pump Lawsuit

To successfully pursue your claim, the following evidence will be necessary:

• Medical records documenting the implantation of the Impella device
• Records showing injuries or death that occurred following device use
• Documentation of all treatments received for complications
• Medical expenses related to additional care required
• Proof of lost wages and impact on earning capacity
• In some cases, statements needed to corroborate organ/heart surgery to illustrate the purpose behind using the Impella device

Damages You Can Recover

Victims in Impella heart pump lawsuits may recover compensation for:

• Medical expenses (past and future)
• Lost wages and diminished earning capacity
• Pain and suffering
• Emotional distress
• Permanent disability or disfigurement
• Loss of enjoyment of life
• Wrongful death damages for surviving family members
• Punitive damages in cases of gross negligence

Impella Heart Pump Recall Information

In October 2024, the FDA initiated a Class I recall of all Impella Heart Pump devices distributed between October 10, 2020, and October 13, 2023. This recall affected over 66,000 devices across the United States.

The recall occurred after a comprehensive inspection of Abiomed’s manufacturing facilities and data during the lifespan of the implanted cardiac catheter, especially for high-risk patients or those undergoing acute PCI.

The recall of Impella Left-Sided Blood Pumps was initiated following the identification of multiple serious complications. Five specific models were added to serious injuries list, all reported directly relating to a recall of the instructions for the LD, CP, CP with SmartAssist, 5.0, and 5.5 devices between October 2020 and October 2023.

Serious injuries and fatalities linked to the Impella heart pumps, specifically with 5.0 cases resulting heart and blood transfusion injuries, have been highlighted by the FDA’s alert regarding a range of marketed Impella Heart Pump devices.

Statute of Limitations for Impella Heart Pump Lawsuits in Pennsylvania

In Pennsylvania, the statute of limitations for product liability claims like the Impella heart pump lawsuit is generally two years from the date of injury or when the injury was first discovered.

However, this timeline can vary depending on several factors:

• The “discovery rule” may extend the deadline if the connection between the device and injury was not immediately apparent
• If the victim is a minor, the statute of limitations may begin once they reach the age of 18
• Wrongful death claims typically must be filed within two years of the date of death

It’s critical to consult with an experienced Impella heart pump attorney as soon as possible to ensure your claim is filed within the appropriate time limits.

See all related medical device lawsuits our attorneys covered so far.

Frequently Asked Questions

1. What is an Impella Heart Pump?

The Impella heart pump is a mechanical device for the heart, particularly the ventricles, which was created with pumping blood in and out of the body. This device becomes crucial in life-threatening situations where immediate heart assistance or circulatory rehabilitation (PCI) – complex procedures that may involve replacement of valves or balloon to open-up blocked arteries.

2. What are the most common injuries from Impella Heart Pumps?

Common injuries include hemolysis (red blood cell destruction), thrombosis, vascular complications, device migration, infection, and heart failure exacerbation. These conditions can lead to permanent disability, organ damage, and in severe cases, wrongful death in patients using Impella devices.

3. How much compensation can I receive for an Impella Heart Pump lawsuit?

Compensation varies based on injury severity, medical expenses, lost wages, and pain suffering. Successful claims may result in six to seven-figure settlements, with wrongful death cases typically receiving higher compensation. Each case is evaluated individually based on specific damages.

4. Is this a class action lawsuit or individual claims?

Most Impella cases are individual personal injury claims consolidated into mass tort litigation rather than class action lawsuits. This approach allows each plaintiff to receive compensation based on their specific injuries while benefiting from the collective legal strategy against Abiomed.

5. How long will my Impella Heart Pump lawsuit take?

Most medical device lawsuits take 1-3 years to resolve. Factors affecting timeline include case complexity, evidence strength, court backlog, and settlement negotiations. Some cases settle earlier, while others requiring extensive litigation may take longer to reach resolution.

6. Can I still file if my Impella procedure was years ago?

Possibly, depending on your state’s statute of limitations and when you discovered the connection between your injuries and the device. Most states allow 2-3 years from injury discovery. Consult an attorney immediately to evaluate your specific timeline requirements.

7. What if a family member died from Impella complications?

If a loved one died from Impella complications, you may be eligible to file a wrongful death lawsuit. The claim can seek compensation for medical expenses, funeral costs, lost income, pain and suffering, and loss of companionship. Contact an attorney to discuss your legal options.

8. What is the cost to hire an Impella Heart Pump lawyer?

Most Impella heart pump attorneys work on contingency fee basis, meaning you pay nothing upfront and attorneys only collect payment (typically 33-40% of recovery) if they win your case. Initial consultations are free, making legal representation accessible to all victims.

Take Action Now: Time-Sensitive Legal Claims

Time is limited to pursue legal action for injuries caused by Impella heart pump devices. In Pennsylvania, you have only 2 years from the date of injury or discovery to file your claim.

Our legal team at Schmidt & Clark offers:

• Free, confidential consultations
• No upfront costs or fees
• Payment only if we win your case
• Decades of experience in medical device litigation
• Personalized attention to your unique situation

Don’t wait until it’s too late to pursue the compensation you deserve for personal injury and emotional distress caused by defective Impella heart pump devices. Our experienced attorneys specialize in complex medical device litigation, including class action lawsuits involving heart pumps.

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References:

1. https://www.fda.gov/medical-devices/medical-device-recalls/abiomed-recalls-instructions-use-impella-left-sided-blood-pumps-due-perforation-risks