Abiomed, J&J Challenge Class Action Lawsuit Over Impella Heart Pump

Following a long record of Impella recalls and regulatory warnings about problems with the heart pump, Abiomed continues to challenge a lawsuit alleging one of the devices caused an Ohio man’s death.

Manufacturers of the Impella heart pump are urging a federal judge to dismiss claims brought by an Ohio woman, who alleges that dangerous design defects associated with the device directly caused her husband’s death.

The Impella is a pencil-sized heart pump that has been used in recent years during certain open-heart procedures, to help maintain circulation. It is inserted through the femoral artery in the leg and carefully guided into the heart’s left ventricle.

Once positioned, the pump is designed to move oxygen-rich blood into the ascending aorta, supporting blood flow throughout the body while the heart is weakened or undergoing surgery. However, the device has been plagued with problems in recent years, and linked to reports of serious and often life-threatening complications among some patients.

In May 2025, Rebecca Lester became one of a number of plaintiffs to bring an Impella heart pump lawsuit, after her husband, Garry, died in 2021 following implantation of the device.

In the complaint, she indicates that shortly after the pump was implanted, her husband’s blood pressure dropped sharply, and doctors later discovered the Impella device had punctured the wall of his heart. The injury triggered a series of complications that led to his death just three days later. The lawsuit contends that manufacturers Abiomed and Johnson & Johnson disregarded years of warnings and known safety issues involving the devices.

Since its introduction, the Impella has been the subject of numerous recalls and safety warnings citing malfunctions, such as valve perforations similar to the one alleged in Lester’s case, many of which have resulted in patient deaths.

In late July, the defendants filed a motion to strike Lester’s class action claims and parts of the litigation, alleging the lawsuit covered too many different products and models for use in different types of patients. In response, U.S. District Judge Patricia A. Gaughan, of the Northern District of Ohio, gave Lester until October 3 to file an amended complaint addressing the defendants’ issues before she began making rulings.

Laster submitted an amended Impella pump lawsuit last month, after which the judge rendered the defendants’ motion to dismiss as moot.

In response, the manufacturers filed memorandums supporting their motion to dismiss (PDF) Lester’s claims, as well as a motion to strike (PDF) the class allegations, on November 7.

“Because the Court has already granted Plaintiff the opportunity to amend her claims to address Defendants’ arguments and yet they remain deficient, the Court should grant Defendants’ motion and dismiss these claims with prejudice.”

– Defendants’ Motion to Strike Plaintiff’s Amended Class Allegations

The defendants argue that the lawsuit violates several provisions of Ohio’s product liability laws and that Lester has not adequately stated a valid claim.

Impella Heart Pump Problems

While the manufacturers seek to have Lester’s claims dismissed, federal health officials have continued to raise concerns about the safety of the Impella device.

In 2023, the U.S. Food and Drug Administration (FDA) announced a Class I recall for Impella Left Sided Blood Pumps, following reports of heart ventricle perforations, which linked the device to 129 injuries and 49 deaths. That same year, another recall was issued for Impella 5.5 with SmartAssist pumps due to purge fluid leaks that led to device malfunctions, heart valve damage and a heightened risk of severe injuries, with 179 related complaints.

Additionally, the FDA issued a Class I recall for Impella RP Flex catheter systems in June 2023, following inadequate safety instructions regarding blood clot risks. This issue was associated with 12 reported injuries and posed a serious risk of death and other complications.

Lester’s complaint is one of at least two Impella wrongful death lawsuits filed against Abiomed and Johnson & Johnson. The other was filed by Christopher Urqhart and Amy Ehlers, who allege that Nancy June Urqhart died from intravascular hemolysis following the use of an Impella 5.5 pump during open heart surgery. Her family indicates the device caused Urqhart’s blood cells to break down, leading to severe complications and death just three days after the procedure.

Impella heart pump lawyers are continuing to investigate similar cases on behalf of patients and families who believe use of the device may be linked to severe injuries and death. Free case evaluations are being provided to help individuals determine whether they may be eligible to pursue a product liability or wrongful death lawsuit.