New York City Abiomed Impella Heart Pump Injury Lawyers

In June 2023, the U.S. Food and Drug Administration (FDA) issued recalls for 66,000 Impella Heart Pumps manufactured by Abiomed and distributed between October 2021 and October 2023, “The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.” 

If you or a family member has been injured by the Abiomed Impella Heart Pump, our NYC product liability attorneys at Douglas & London in New York, NY, can pursue compensation while you concentrate on healing. With our assistance, clients injured by defective products have collected millions in compensation. Call us 24/7 or reach us online to schedule a complimentary case review to determine if you have grounds to bring an Abiomed Impella Heart Pump lawsuit.  

What is the Abiomed Impella Heart Pump? 

The Abiomed Impella Heart Pump is a small, minimally invasive mechanical device used to assist the heart in pumping blood. It is designed for patients with severe heart failure or those undergoing high-risk procedures, such as stent placements or angioplasty.  

The Impella pump is inserted through a catheter into the heart and positioned in the left ventricle, where it helps to maintain blood flow, reduce the heart’s workload, and improve circulation. Its primary function is temporarily supporting heart function, allowing the heart to recover, or providing a bridge to more definitive treatments like surgery or transplantation. 

Abiomed Impella Heart Pump Recall  

Abiomed’s Impella heart pumps have been recalled due to serious safety concerns. The primary issue involves the risk of the pump catheter perforating the left ventricular wall during operation, which can lead to severe complications such as ventricular rupture, hypertension, insufficient blood flow, and even death.  

Common Injuries Associated with the Impella Heart Pump 

To date, the FDA has received over 129 reports of severe injuries and 49 deaths associated with Impella heart pump implantation over a two-year period. In response, it has issued a Class 1 Abiomed heart pump recall, indicating problems linked to the device could potentially result in serious injury or death.   

The recall does not remove the product from the market. However, it updates instructions for use, emphasizing precautions clinicians must take, especially when treating patients with certain conditions, like those who have undergone transcatheter aortic valve replacement (TAVR). Additional recommendations include careful positioning and monitoring during procedures. ​Complications have included the following:   

Vascular Complications 

The vascular complications linked to Abiomed’s Impella Heart Pumps include serious risks such as ventricular wall perforation, which can cause life-threatening conditions like free wall rupture. Other issues include cardiac tamponade, where fluid accumulates around the heart, impairing its function, and hemolysis, or damage to red blood cells, leading to anemia.  

Additionally, thromboembolism can occur due to the release of harmful particulates or damage to the impeller blades, potentially resulting in stroke or other embolic events.​ 

Blood Clots and Embolism Risks 

The Impella RP Flex with SmartAssist is used in patients with acute right heart failure after left ventricle assist implantation. The FDA determined that its instructions do not fully address the risk of treating patients with clotting disorders, increasing their risk of blood clots and embolisms.  

The agency issued a 2023 Class 1 recall because “the catheters’ Instructions for Use (IFU) do not appropriately address precautions for health care providers to take when treating patients whose anticoagulation clotting time is below the recommended value.”  

Device Malfunctions and Failures  

Additionally, damage to the device, particularly to the motor’s spinning blades, can occur if the motor’s housing comes into contact with the stent in patients undergoing transcatheter aortic valve replacement (TAVR). This can impede blade function, reducing or stopping blood flow entirely. Also, broken blade pieces can enter the patient’s bloodstream, increasing the risk of heart wall damage.  

Who Can File a Lawsuit? 

Individuals eligible to file an Abiomed Impella Heart Lawsuit include patients who experienced complications or injuries such as heart perforation, severe bleeding, or stroke due to the malfunction of the device. Additionally, family members of patients who died from complications related to the Impella heart pump can file a wrongful death lawsuit. 

To pursue a claim, the plaintiff must prove that the device was defective in design or manufacture or lacked adequate warnings and that this directly caused the injury or death. The claim must be filed within the three-year statute of limitations in New York. It’s wise to contact a NYC medical device lawyer at Douglas & London for guidance to ensure compliance with the statute of limitations.  

Filing a Lawsuit 

To file a product liability claim for an Abiomed Impella Heart Pump in New York, the process involves several key steps: 

  1. Consult an Attorney: The first step is to consult a product liability lawyer at Douglas & London, experienced in medical device claims. We will review your case to determine if the Impella Heart Pump caused your injury or the death of a loved one due to defects like malfunction, inadequate warnings, or complications such as heart perforation or lack of blood flow​. 
  2. Evidence Collection: We will gather medical records, expert testimonies, and documentation to prove the device was defective and directly responsible for the injury. This could involve showing manufacturing or design flaws or failure to provide adequate instructions​. 
  3. Filing the Lawsuit: Depending on the circumstances, the claim will be filed in court, typically against the manufacturer (Abiomed) and possibly healthcare providers.  
  4. Pursuing Compensation: If successful, you may recover compensation for medical bills, lost wages, pain and suffering, and other related damages. In cases of wrongful death, family members can also seek compensation​. 

        Throughout the process, we will advocate on your behalf, negotiate with the defense, and potentially proceed to trial if necessary. 

        Contact Douglas & London for a Free Consultation 

        Drug and medical device manufacturers have deep pockets and significant legal resources to fight lawsuits. It takes an aggressive legal team to take on these large corporations. At Douglas & London, we have the experience and determination to take on these companies and secure justice for our clients. We have recovered over $18 billion in settlements and verdicts to date.  

        Schedule a free, no-obligation consultation today. From the heart of Manhattan’s Financial District, we represent clients across New York City and throughout New York State. Since we work on a contingency fee basis, you will not pay attorney’s fees unless we win compensation for your injuries.