Updated Impella Lawsuit Submitted Over Death Linked to Pump Used During Cardiac Surgery

The family of a Missouri woman, who allegedly died due to problems with an Impella heart pump used during cardiac surgery, has filed a motion for leave to amend their complaint, after the woman’s husband has passed away, leaving her daughter as the only surviving plaintiff.

The original wrongful death lawsuit was brought in the Circuit Court for the City of St. Louis in September 2024, by the family of Nancy June Urqhart. However, the Impella lawsuit was subsequently removed to the U.S. District Court for the Eastern District of Missouri by the manufacturer, where it is currently pending.

The Impella pump is a small device about the size of a pencil, which was used during an open-heart procedure Urqhart underwent in September 2022. The Impella is inserted through a blood vessel in the leg (femoral artery) and guided into the heart’s left ventricle, where it is supposed to move oxygen-rich blood from the ventricle into the ascending aorta, helping maintain blood flow to vital organs during surgery.

However, the lawsuit indicates that design defects caused the Impella pump to fail during the cardiac surgery.

Impella Patient Risk Concerns

The lawsuit comes amid growing concerns about Impella patient risks, following a number of Impella recalls and warnings issued by federal regulators in recent years.  Those concerns have included patient survival rates, heart valve damage and blood clot risks.

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 these recalls, lawyers across the U.S. began 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.

According to the original Urqhart family lawsuit, an Impella pump was used to keep her heart functioning during a mitral valve replacement in September 2022. However, instead of supporting her recovery, the Impella 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.

In a Motion for Leave to Amend (PDF) filed on January 31, the Urqhart family announced that Nancy Urqhart’s widower, Christopher Urqhart, who was one of the original plaintiffs, has now also died.  As a result, Amy Ehlers, the surviving daughter, submitted an updated Impella lawsuit.

The amended complaint not only adjusted its language due to the husband’s death, but that it also sets out the claims with more specificity.

Abiomed Trying to Have Impella Lawsuit Dismissed

Shortly after the lawsuit was removed to the federal court system last November, the manufacturer Abiomed filed a motion to dismiss the original complaint, claiming the family failed to state a proper claim, and that the lawsuit was preempted by federal law because the Impella device was approved for use by the FDA.

The family filed an opposition brief last month, 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.

The company replied in mid-January, but no decision on the motion has yet been announced. It is unclear what impact the amended complaint will have on the pending motion.