Impella Pump Lawyers Involved in Class Action Lawsuit To Meet With Judge July 29

Lawsuit claims the manufacturers failed to address known risks of left ventricle perforations and design defects linked to the Impella heart pump.

A federal judge will meet with lawyers involved in an Impella heart pump class action lawsuit late next month, to review the steps that are needed to begin preparing the case for trial or exploring a potential resolution for the claims, which involves allegations that the device was defectively designed.

The Impella is a small pump that is about the size of a pencil, which is used during open-heart procedures. The device is inserted through the femoral artery in the leg and guided into the heart’s left ventricle. Its purpose is to assist circulation by transferring oxygen-rich blood from the ventricle into the ascending aorta, ensuring a steady blood flow to vital organs during surgery.

However, since they were introduced, Impella heart pumps have been plagued by problems, resulting in multiple recalls and dozens of patient deaths, as well as a class action lawsuit seeking damages for individuals who had one of the devices placed in their body.

Impella Heart Pump Problems

In recent years, regulators have warned of lower-than-expected patient survival rates, heart valve damage and blood clot risks linked to Impella pumps.

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.

One of the alleged deaths linked to the Impella heart pumps was Garry D. Lester of Ohio, who died of a fatal heart injury in 2021. His wife, Rebecca, filed an Impella class action wrongful death lawsuit against Abiomed, Inc. and Johnson & Johnson, in late May 2025, seeking damages for herself as well as similarly situated families.

The wrongful death lawsuit alleges Abiomed and Johnson & Johnson failed to act on known safety problems with the Impella heart pump, including risks of left ventricle perforations and manufacturing defects. Lester seeks class action status to also pursue damages on behalf of others who were seriously injured or killed by Impella pumps, claiming the companies withheld critical warnings, violated post-market safety obligations, and misled patients and physicians about the product’s safety.

Although Abiomed issued a technical bulletin in October 2021, warning its sales force about the risk of left ventricle perforations linked to the Impella, the complaint notes that these warnings were never incorporated into the official Instructions for Use or shared directly with physicians or patients. 

Lester claims it was not until September 2024, more than three years after her husband’s death, that a medical professional formally linked the Impella device to the fatal injury.

The case has been assigned to U.S. District Judge Patricia A. Gaughan in the Northern District of Ohio, who issued a Notice of Case Management Conference (PDF) earlier this month, scheduling the initial case management conference on the litigation for July 29, which will be held via videoconference.

According to the order, Impella pump lawyers involved in the case will be expected to bring the judge up to date on the status of the litigation at the time of the conference, with all other pretrial proceedings stayed in the meantime. Judge Gaughan has directed the parties to meet before the initial conference, and exchange basic information on the case.

Impella Heart Pump Wrongful Death Lawsuits

In addition to the Lester complaint, at least one other Impella wrongful death lawsuit has been filed over problems linked to the Impella heart pump. In a case brought by Christopher Urqhart and Amy Ehlers, the family alleges that Nancy June Urqhart died after suffering intravascular hemolysis following the use of an Impella 5.5 pump during open heart surgery.

According to the complaint, the device caused her blood cells to break down, leading to severe complications that resulted in her death just three days after the procedure.

The lawsuit raises concerns that Abiomed failed to adequately warn healthcare providers about the potential for Impella pumps to cause blood-related injuries, and continued to market the devices despite known design issues. Like other claims, the family is seeking compensation for the loss of a loved one and holding the manufacturer accountable for allegedly placing patients at unnecessary risk.

As concerns around the device continue to mount, Impella heart pump lawyers are continuing to investigate similar cases on behalf of patients and families who believe an Impella may have caused injury or 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.