Abiomed Impella Heart Pumps Recalled Due to Deaths and Serious Injuries

The United States Food and Drug Administration (FDA) has issued a Class I Recall, the most serious type of recall for medical devices, for the risk of serious injuries and death in patients.

The March 2024 recall specifically mentions the risk of serious injuries and death in patients due to the potential for the Impella pump catheter to perforate the wall of the left ventricle in the heart, potentially leading to heart perforation, hypertension, lack of blood flow, and in tragic cases, death.

The FDA reported 129 serious injuries and 49 reports of death linked to the Impella Heart Pump devices.

Recalled Impella Heart Pump devices include:

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

Impella Heart Pump Recalls and Regulatory Action (2023 & 2024)

Impella Heart Pumps are designed by Abiomed, a company acquired by Johnson & Johnson MedTech in late 2022, and have faced significant safety and operational challenges over recent years.

Multiple recalls were placed on Impella Heart Pumps throughout 2023, with an official warning being sent to the manufacturer in October 2023 by the US Food and Drug Administration.

• In June 2023, Abiomed recalled Impella devices due to complications that included leaking purge fluid and adverse interactions with transcatheter aortic valve replacement (TAVR) implants.
• In July 2023, the FDA classified this recall as Class I, indicating that these complications could lead to serious injuries or death.
  • This classification came after reports of 30 complaints, 26 injuries, and four deaths directly linked to the devices.
• In October 2023, the FDA sent an official warning letter to Abiomed for failing to report quality problems and for selling its Impella Connect System without FDA authorization or premarket approval.
  • The warning letter addressed systemic failures in reporting adverse events and corrections.

The US Food and Drug Administration’s action on Impella Heart Pumps reached a new level of publicity in March 2024, with Abiomed recalling 66,000+ devices and the FDA issuing a Class I Recall.

The 66,390 Impella Left Sided Blood Pumps that were recalled were distributed in the United States between October 2021 and October 2023.

The March 2024 recall is a significant escalation from previous warnings, as it addresses the serious risks of left ventricle perforation—a condition linked to at least 49 deaths and numerous injuries.

The recall was predicated on the device’s potential to cause severe adverse health consequences, including death, due to the catheter’s risk of cutting through the ventricle wall.

Abiomed Updates Patient Safety Instructions

In response to the recall and heightened safety concerns surrounding the Impella Heart Pumps, Abiomed took steps to enhance patient safety through updated instructions and communications.

These measures are aimed at mitigating risks and ensuring the device is used as safely as possible:

• Recalled Instructions for Use: Abiomed recalled the Instructions for Use (IFU) for the Impella devices, including guidance on safe insertion, operation, and continuous monitoring of devices.
• Urgent Medical Device Correction Letters: In a direct communication to healthcare providers in December 2023, Abiomed issued Urgent Medical Device Correction letters. These letters contained critical updates to the device instructions, underscoring the importance of adhering to these new guidelines to prevent adverse patient outcomes.

About the Impella Heart Pumps

The Abiomed Impella Heart Pump is the world’s smallest heart pump, designed to provide temporary support for the heart’s main pumping chamber, the left ventricle, during high-risk medical procedures or in the aftermath of severe heart conditions.

Impella Heart Pumps have been used to treat Acute Myocardial Infarct (AMI) cardiogenic shock.

The device functions by being inserted through a small incision in the leg and guided into the heart, where it helps by directly pumping blood from the left ventricle into the ascending aorta.

This mechanism aids in reducing the workload on the heart by temporarily taking over the pumping function, which is crucial during periods when the native heart is weak or in recovery.

By doing so, the Impella supports the heart’s ability to recover its normal function, offering a vital lifeline for patients undergoing complex cardiac procedures or those in cardiogenic shock following a heart attack.

What Injuries are Linked to the Abiomed Impella Heart Pump?

The Abiomed Impella Heart Pump aims to support patients during high-risk procedures or in the aftermath of heart failure.

Injuries associated with the device typically occur when its catheter, designed to be inserted into the heart’s ventricle, inadvertently perforates or tears the heart muscle, leading to severe complications.

These events can result in a range of serious adverse health outcomes, often requiring immediate medical intervention to prevent fatal consequences.

Certain patients, including those suffering from heart disease, may be at a higher risk for complications.

Possible injuries and complications linked to the device include:

• Perforation of the left ventricle wall
• Severe internal bleeding
• Cardiogenic shock
• Lack of blood flow to critical organs
• Hypertension
• Hemolysis (destruction of red blood cells)
• Infection at the site of insertion
• Adverse interactions with other cardiac devices (e.g., TAVR implants) leading to device malfunction or failure

How are Impella Heart Pumps Causing Death?

Deaths linked to Impella Heart Pumps can occur through a sequence of critical events initiated by the device’s malfunction or improper use by health care professionals.

When the pump’s catheter perforates the wall of the left ventricle, it can cause severe internal bleeding, leading to immediate hemodynamic instability.

Perforation can also lead to acute cardiac tamponade, a rapid accumulation of blood in the pericardium that compresses the heart, preventing it from beating effectively.

If blood flow is significantly disrupted or stopped, vital organs quickly become deprived of oxygen, leading to multi-organ failure and, ultimately, death.

Death from Impella Heart Pump complications can possibly occur as follows:

1. Perforation of the Heart Wall: Direct mechanical damage to the heart muscle can lead to catastrophic bleeding within the chest cavity.
2. Hemodynamic Instability: The patient’s blood pressure and circulation can rapidly deteriorate, leading to shock and inadequate blood supply to organs.
3. Cardiac Tamponade: Accumulation of blood in the pericardial space compresses the heart, critically reducing its ability to pump blood.
4. Multi-Organ Failure: Prolonged lack of adequate blood supply results in the failure of multiple organ systems, a condition often irreversible and fatal.

Were You or a Loved One Injured by the Impella Heart Pump?

The increasing number of injuries and tragic deaths associated with Impella Heart Pumps has raised serious concerns within the medical and legal communities.

Given the severity of these cases, where individuals have suffered due to perforations and other complications, the scrutiny on patient safety and device efficacy is higher than ever.

Lawyers who specialize in medical device litigation are actively investigating these incident and assessing the potential for legal action against Abiomed, the manufacturer, and Johnson & Johnson, the parent company of Abiomed.

This investigation is focused on whether the company adequately disclosed the risks, complied with regulatory standards, and implemented necessary precautions to protect patients.

Lawsuits for defective and dangerous medical devices aim to hold the manufacturer accountable and seek justice for affected patients and their families.

If you or a loved one were injured by the Abiomed Impella Heart Pump, you may be eligible to file a claim and seek compensation.

Contact our law firm today to learn more about your legal options.

You can also use the chatbot on this page to get in touch with our team instantly.

What Should I Do If I Was Injured by the Impella Heart Pump?

If you or a loved one has been injured by the Impella Heart Pump, it’s crucial to take immediate steps to ensure your safety and protect your legal rights

Prompt action can help in addressing the injury and potentially prevent others from similar harm:

1. Seek Immediate Medical Attention: Prioritize your health by consulting with healthcare professionals to assess and document any injuries related to the Impella Heart Pump.
2. Report the Incident to the FDA: File a report with the FDA’s MedWatch program, which monitors adverse reactions and quality problems with medical devices. Reporting can be done online, via mail, or fax.
3. Gather and Preserve Evidence: Collect any medical records, device information, and correspondence related to your use of the Impella Heart Pump.
4. Keep a Detailed Record of Your Experience: Note any symptoms, medical appointments, and how the injury has impacted your life.
5. Contact a Lawyer Specializing in Medical Device Litigation: Seek legal advice from a lawyer with experience in medical device litigation to discuss your options and potentially pursue a claim against the manufacturer.

What Should I Do If My Loved One Died due to the Impella Heart Pump?

If your loved one passed away due to complications with the Impella Heart Pump, we offer our deepest condolences for your loss.

Navigating this difficult time requires support and guidance to address the aftermath of such a tragedy.

Here are the steps you should consider:

1. Obtain Medical Records: Secure copies of your loved one’s medical records related to the Impella Heart Pump treatment. These documents are vital for understanding the circumstances surrounding their passing.
2. Report to the FDA: Inform the FDA’s MedWatch program about the incident. This action helps the agency track device-related fatalities and can contribute to preventing future occurrences.
3. Document Everything: Keep a detailed record of all events leading up to and following your loved one’s use of the Impella device, including any communication with healthcare providers and the device manufacturer.
4. Seek Emotional Support: Consider reaching out to support groups for families. Sharing experiences can offer comfort and solidarity during this challenging time.
5. Consult with a Specialized Attorney: Contact an attorney who is experienced in medical device litigation to explore your legal rights and options. A lawyer can offer sensitive and comprehensive advice on how to proceed with a potential wrongful death claim.

Remember, you’re not alone in seeking answers and accountability.

Taking these steps can be a part of honoring your loved one’s memory and ensuring that justice is pursued.

TorHoerman Law: Investigating Impella Heart Pump Lawsuit Claims

Adverse effects of medical devices like the Impella Heart Pump can profoundly impact individuals’ quality of life, leading to significant physical, emotional, and financial strain.

For families who have tragically lost a loved one due to complications with these devices, the pain and loss experienced can be overwhelming, leaving a lasting void and raising serious questions about safety and accountability.

Our lawyers are currently investigating the possibility of litigation against manufacturers, which would aim to hold responsible parties accountable and seek justice for those affected and their families.

If you or a loved one have been injured or tragically passed away due to the use of an Abiomed Impella Heart Pump, you may be eligible to file a claim.

Contact our law firm for a free, no-obligation consultation.

You can also use the chatbot on this page to get in touch with our team.

We’re here to help you.