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Abiomed Impella Heart Pump Lawsuit

Abiomed Impella heart pump lawsuits claim the device is defective and caused serious injuries or death. Abiomed recalled the device because it could break during an operation, leading to reduced blood flow or total pump stoppage. Litigation is in the early stages.

This is an active lawsuit

See If You Qualify for an Abiomed Impella Heart Pump Lawsuit

If you were seriously injured by the Abiomed Impella heart pump or lost a loved one who was seriously injured by the defective device, you may be entitled to compensation.

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Last Modified: May 14, 2024
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Latest Abiomed Impella Heart Pump Lawsuit Updates

Severely injured patients and the loved ones of those who died from a defective Impella heart pump medical device are filing lawsuits against the manufacturer, Abiomed. These filings are still in the early stages as patients and families consult with experts in product liability and wrongful death cases.

The Abiomed Impella heart pump had caused four deaths as of July 2023. Current lawsuits state that the manufacturer and sellers endangered customers and have a legal responsibility for the harm the defective devices caused.

  • May 2024: Litigation remained in the early stages, and no trials have been scheduled.
  • March 2024: There have been no new developments in this litigation, though lawyers continue to accept cases.
  • December 2023: Lawyers continue to investigate lawsuits. So far, there have been no global settlements or trials scheduled.
  • October 2023: FDA announced it sent a warning letter to Abiomed saying the company's responses to the FDA's inspection of its manufacturing facility in Massachusetts were inadequate. The FDA determined the company has been marketing its Impella Connect system without proper premarket approval.
  • September 2023: Injured patients or loved ones of those severely injured or who died are currently working with lawyers to file lawsuits over the recalled pump.
  • July 2023: The FDA classified the Abiomed Impella blood pump recall as a Class I recall. So far, there are 30 complaints, 26 injuries, and four deaths reported.
  • June 2023: Abiomed recalled Impella blood pump devices distributed from May 1, 2021, to present day.
  • March 2018: Abiomed paid a settlement of $3.1 million for allegations that it purchased expensive meals for physicians in an effort to get them to purchase its pumps.

The current Abiomed heart pump lawsuits differ greatly from the 2018 settlement. Past lawsuits were for claims that the manufacturer wrongfully tried to influence physicians to buy its products. The current developing lawsuits focus on injuries and wrongful death claims directly caused by the defective medical device.

Why Are People Filing Impella Heart Pump Lawsuits?

Patients and family members of those who underwent transcatheter aortic valve replacement are suing Abiomed over claims the Impella left sided blood pumps are causing serious injuries or even death.

Lawsuits claim the manufacturer failed to warn doctors that the pumps could malfunction and fracture during the TAVR procedure.

“The damaged Impella system may have reduced blood flow or pump stop, which may delay therapy or fail to provide enough support to the patient. This could be life threatening in people who require high levels of support. There is also a risk that pieces of the broken blades could enter the patient’s bloodstream.”
Food & Drug Administration

Many people have filed product liability lawsuits for Impella heart pump complications such as failure and other serious injuries, including brain damage, that resulted from lack of blood flow.

Some patients needed open-heart surgery to remove the device or fractured pieces of it. Family members of loved ones who died as a result of the Impella device are filing wrongful death cases.

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Who Can File an Abiomed Impella Heart Pump Lawsuit?

People who were severely injured as a result of the Abiomed Impella heart pump and those who lost a loved one or whose loved one was severely injured by a defective device can file a lawsuit. An experienced product liability or wrongful death attorney can review the specific details of your case to determine eligibility.

Lawsuit criteria include:
  • Plaintiff had a heart valve replacement surgery in which the doctor stated the pump failed or became damaged during the procedure.
  • Plaintiff suffered brain damage from lack of blood flow or another serious injury, or had a loved one die.
  • People may also be eligible if they underwent an operation during a heart attack or cardiogenic shock that used a temporary blood pump.

Wrongful death claims citing product liability must prove that the heart pump was dangerous because it was defective, either as the result of a manufacturing issue, design flaw or inadequate instructions conveying any necessary warnings.

The claim also needs to show that the defect caused the patient’s death. The main defect of the Abiomed Impella heart pump is a damaged purge sidearm, which increases the risk of purge fluid leakage.

Status of Abiomed Impella Heart Pump Recalls

The Abiomed Impella heart pump recall is a Class 1 recall, initiated on June 14, 2023. The FDA identifies this as the most serious type of recall because defective medical devices can cause serious injuries or death. The recall includes more than 7,895 units of the pump, distributed from May 1, 2021, to present day.

Timeline of Impella Heart Pump Recalls:
  • June 29, 2023: The Impella RP Flex with SmartAssist, distributed from Nov. 1, 2022, to the present, is recalled.
  • June 14, 2023: Abiomed recalls its Impella left sided blood pumps. Patients and their families are still filing lawsuits.
  • April 17, 2023: Impella 5.5 with SmartAssist devices distributed between Sept. 28, 2021, and March 6, 2023, are recalled.

Abiomed advises that doctors should not use the specified device in any operation unless an alternative is unavailable. In these cases, the company provides steps to follow to limit the risk of the pump causing injury or death.

According to the FDA recall notification’s actions for customers, the pump is “not being removed from the field and does not need to be returned.”

How to File an Abiomed Heart Pump Lawsuit

The first step in filing an Abiomed Impella heart pump lawsuit is to contact an experienced product liability lawyer. Lawsuits may be filed by injured patients or family members filing on behalf of a patient or their estate.

Filing an Impella Lawsuit:
  1. Begin the legal process by consulting an experienced product liability lawyer.
  2. Provide the lawyer with details and documentation of you or your loved one’s medical history, including the timeline of relevant events.
  3. The law firm will assist you in gathering all the documents needed to review your case.
  4. Next, your law firm will determine if you have a viable case and assess the best approach for filing a lawsuit.
  5. Your lawyer will file the claim on your behalf and guide you through the process.

The compensation the plaintiff may receive from a successful lawsuit or settlement depends on the type of injuries they sustained and the severity. Damages may include past and future medical treatment, loss of income, and pain and suffering.

Proving the claims that a medical device was defective and responsible for causing an injury or death is a complicated process. Plaintiffs also need to show that the manufacturer was negligent in patient safety when distributing a faulty device. It’s critical that you retain a lawyer who is familiar with defective medical device cases.

Please seek the advice of a medical professional before making health care decisions.