Abiomed Impella Lawsuit Alleges Heart Pump Caused Wrongful Death of Illinois Woman

Family filed the Impella wrongful death lawsuit, alleging the device was defective and caused severe complications during cardiac surgery, leading to a preventable death.

The family of a Missouri woman has filed a wrongful death lawsuit, alleging that a defective Impella heart pump caused severe complications during cardiac surgery, resulting in her tragic and avoidable death.

The Abiomed Impella pump is a small device used to support patients with severe heart conditions. It is about the size of a pencil, and is inserted through a blood vessel in the leg (femoral artery) and placed in the heart’s left ventricle. The pump moves oxygen-rich blood from the ventricle into the ascending aorta, helping maintain blood flow to vital organs.

Impella devices are typically used during complex heart procedures or when a patient’s heart is too weak to pump effectively. This includes high-risk percutaneous coronary interventions (PCI) to open blocked arteries or managing cardiogenic shock, a condition where the heart cannot pump enough blood to meet the body’s needs. However, concerns have emerged in recent years about the safety of the device.

Impella Heart Pump Recalls Highlight Safety & Fatality Concerns

While Abiomed’s Impella heart pump has been marketed as an innovative solution to assist heart function during high-risk procedures since it was approved in 2008, there have been a number of Impella recalls and warnings issued by federal regulators over problems with the device.

In 2019, the FDA issued a letter to healthcare professionals indicating that while initial clinical trials reported a 73% survival rate among patients, real-world interim results from 2019 showed only a 28% survival rate among Impella patients transitioning to long-term therapy.

In 2023, the FDA issued a Class I recall for Impella Left Sided Blood Pumps after reports of heart ventricle perforations, linked to 129 injuries and 49 deaths. That same year, a recall for Impella 5.5 with SmartAssist pumps addressed purge fluid leaks that caused device failures, heart valve damage and an increased risk of severe injuries, with 179 related complaints.

In June 2023, the FDA issued a Class I recall for the Impella RP Flex catheter system due to inadequate safety instructions about blood clot risks. These deficiencies were linked to 12 reported injuries and posed a significant risk of severe complications or death.

Following the series of recalls, lawyers across the U.S. have been investigating potential Impella heart pump lawsuits, and wrongful death lawsuits for individuals and families who claim the manufacturer knew about Impella heart pump problems for years, yet placed profits before patients safety by failing to remove the products from the market.

Impella Heart Pump Wrongful Death Lawsuit

What is believed to be one of the first Impella heart pump lawsuits was filed in the Circuit Court for the City of St. Louis in September 2024, over the wrongful death of Nancy June Urqhart, and the complaint (PDF) was removed to the federal court system in November 2024, where the manufacturer is now attempting to convince a federal judge to dismiss the claim.

The lawsuit was brought by Urghart’s widower and daughter, Christopher Urqhart and Amy Ehlersbrought, respectively, who claim that the Impella heart pump was defective and directly caused the death of their loved one.

Urqhart underwent open-heart surgery, including a mitral valve replacement, at SSM St. Louis University Hospital on September 9, 2022, according to the complaint. During the procedure, the Impella 5.5 device was utilized to support her heart function.

However, instead of supporting her recovery, the device caused “intravascular hemolysis,” a dangerous breakdown of red blood cells within the blood vessels. According to the lawsuit, the Impella device used during surgery was dangerously defective and improperly manufactured, with a specific flaw that prevented the pump’s lead from releasing properly after the procedure.

This defect disrupted normal blood circulation, leading to severe complications that culminated in Nancy’s death just three days later, on September 12, 2022, according to the complaint.

Christopher Urqhart and Amy Ehlersbrought describe extensive damages as a result of the device’s defective design, including the loss of companionship, guidance, and support, as well as financial burdens, such as funeral expenses. The lawsuit also highlights the suffering Nancy endured in the days leading up to her death.

The lawsuit presents claims for negligence, defective design, failure to warn and breach of implied warranty of merchantability. It also seeks exemplary damages, alleging that the company showed complete disregard for patient safety.

Abiomed Seeks To Dismiss Impella Lawsuit

Shortly after removing the Impella lawsuit to the federal court system, Abiomed filed a Motion for Judgement (PDF) based on the pleadings, arguing that the family failed to state a claim upon which relief could be granted, and that the claims are preempted by federal since the product went through FDA pre-market approval.

The family filed an opposition (PDF) on January 3, 2025, outlining the basis for their claim and maintaining that Abiomed should not be insulated from liability based on the FDA approval, indicating that the manufacturer failed to inform the Court that the product has been found to have defects and flaws in the manufacturing process, which resulted in a recall of the product involved in the case.

“Plaintiffs are the husband and daughter of Nancy June Urquhart, deceased, who died on September 12, 2022, three days after… an open-heart surgical procedure during which a product designed, manufactured and sold by the Defendant and used in this surgical procedure caused Nancy June to suffer intravascular hemolysis, which caused her death,” the family states in their response. “The product… was used as a pump during Nancy June’s cardiac surgery and this was the purpose for which it was manufactured. However, this product was unreasonably dangerous when sold by Defendant and as a result, it failed, causing Plaintiffs to lose their wife and mother.”

Abiomed filed a final Reply (PDF) this week, on January 13, 2025, indicating that the lawsuit should be dismissed since the plaintiffs have failed to articulate what the specific manufacturing defect was, or how that defect caused Nancy June Urquhart’s injuries.

Abiomed also urged the court to deny the plaintiffs’ request to amend their complaint or conduct further discovery, arguing that any amendments would be futile. The company stated that the plaintiffs had not demonstrated how they could overcome the legal barriers of federal preemption or substantiate their claims with new evidence. The court’s decision on Abiomed’s motion in this early Impella lawsuit will significantly shape the future of not only this case, but also others that could follow.