Impella Pump Class Action Lawsuit Alleges Defects Caused Perforated Left Ventricle, Wrongful Death

Man died just three days after receiving the Impella heart pump, according to allegations raised in wrongful death lawsuit filed by his family.

According to a recently filed wrongful death lawsuit, an Ohio man died of a left ventricle perforation only a few months before Abiomed released a bulletin instructing doctors how to avoid puncturing the heart when using Impella heart pumps.

The complaint (PDF) was brought by Rebecca Lester in the U.S. District Court for the Northern District of Ohio on May 27, presenting claims on behalf of herself and the estate of her late husband, Garry Lester. The lawsuit names Abiomed, Inc. and its parent company, Johnson & Johnson, as defendants, alleging that their Impella CP heart pump caused Garry Lester’s fatal heart injury in 2021.

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.

According to the wrongful death lawsuit, 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 pump, claiming the companies withheld critical warnings, violated post-market safety obligations, and misled patients and physicians about the product’s safety.

Impella Heart Pump Problems

Since it was introduced, the Impella heart pumps have been plagued by problems, resulting in multiple recalls and dozens of patient deaths. In recent years, regulators have warned of lower-than-expected patient survival rates, heart valve damage and blood clot risks.

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.

Earlier this year, another Impella recall was announced due to the risk that improper positioning during insertion could result in making contact with the guidewires, which could cause the device to shut down, or result in serious injury or death.

In recent years, lawyers throughout the United States have begun evaluating potential Impella heart pump lawsuits on behalf of individuals and families who allege that the manufacturer was aware of Impella heart pump risks for years, but failed to act, placing a desire for profits over patient safety.

2025 Impella Class Action Lawsuit

According to a recently filed lawsuit, Garry Lester underwent a high-risk cardiac procedure on May 27, 2021, during which doctors implanted an Impella CP heart pump into his left ventricle. Shortly after the device was placed, Lester’s blood pressure dropped sharply. Doctors later determined the pump had perforated the wall of his heart, leading to a series of complications that resulted in his death just three days later, on May 30.

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.

“Abiomed failed to ensure their Impella pump which caused Decedent’s serious injury and death was not adulterated in any way, was manufactured according to its approved specifications, and contained sufficient Instructions for Use incorporating post market acquired knowledge of harmful effects in a way to avoid heart wall perforation, other injuries, and death,” the lawsuit states. “Abiomed failed to warn users of the Impella CP device and actively marketed the Impella CP device as being safe despite the substantial risk of harm.”

The lawsuit seeks class action status for all individuals who had an Impella heart pump implanted and who suffered cardiovascular injuries or death between January 1, 2018 and March 21, 2024. 

Lester’s wife and estate present claims of product liability, breach of warranty, fraud, survivorship, violations of Ohio consumer sales practices, wrongful death and loss of consortium. She seeks both punitive and compensatory damages.

Impella Heart Pump Lawsuits Investigated Nationwide

Amid the growing number of Impella recalls issued in recent years, Impella heart pump recall lawyers are investigating cases for individuals who have received the devices and experienced any of the following injuries:

Lawyers provide free consultations and claim evaluations to help individuals throughout the United States determine whether financial compensation or settlement benefits through an Impella heart pump lawsuit may be available.