Impella Heart Pump Lawsuit: Injuries, Recalls, and Defendants

If you or a family member was seriously injured or died after being treated with an Abiomed Impella heart pump, an Impella heart pump lawsuit may be an option. Individual product liability and wrongful death cases have been filed in state and federal courts since January 2025, and at least two proposed class actions are pending against Abiomed and its parent company, Johnson & Johnson. As of mid-2026, no multidistrict litigation has been established, no global settlement exists, and no case has gone to trial.¹

Who Is Suing and What They Claim

The first known Impella wrongful death lawsuit was filed on January 21, 2025, in the Circuit Court for the City of St. Louis. It alleged a defective Impella 5.5 caused intravascular hemolysis — the destruction of red blood cells — that contributed to a patient’s death.²

In May 2025, a proposed class action was filed in the Northern District of Ohio on behalf of Rebecca L. Lester, individually and as administrator of the estate of Garry D. Lester. The case, numbered 1:25-cv-01081, names both Abiomed and Johnson & Johnson as defendants. It brings claims for strict products liability based on manufacturing defects, design defects, and inadequate instructions, along with breach of warranty, fraud, Ohio consumer protection violations, and wrongful death. The complaint alleges that the manufacturers deliberately concealed knowledge of left ventricle perforations and manufacturing “burrs,” and that they manipulated post-market regulatory processes.³

A separate class-action wrongful death lawsuit filed in June 2025 sought class status for injuries and deaths that occurred between January 2018 and March 2024. In November 2025, an amended complaint in Ohio federal court alleged design defects caused fatal left ventricle perforations.²

Across the filings, plaintiffs share a common theory. They allege the Impella pump catheter is prone to perforating or tearing the heart muscle, particularly the wall of the left ventricle, and that this risk was not adequately communicated to physicians or patients. They also allege the manufacturers knew about perforation risks, purge system failures, and other defects for years before issuing recalls or updating warnings.⁴

Injuries and Deaths Named in the Lawsuits

The complications plaintiffs have raised include:

Cardiac tamponade, meaning pressure on the heart from blood collecting in the surrounding sac
Left ventricle perforation and severe internal bleeding
Cardiogenic shock
Hemolysis
Organ failure
Stroke
Death⁴

A 2025 study published in Catheterization and Cardiovascular Interventions analyzed 47 MAUDE reports of deaths specifically associated with the Impella 5.5. Of the 43 cases the researchers included, cardiac perforation was the most frequent complication, occurring in 16 cases and accounting for 37 percent of deaths in the cohort. Device malfunction, including pump stoppage from electrical failure or lumen damage, accounted for another eight cases. The authors noted that underreporting is likely because MAUDE relies on voluntary submissions.⁵

The scale of reported problems is larger than any single recall notice suggests. The FDA’s MAUDE database contains roughly 39,275 reports related to Impella devices filed since January 2019, including 4,923 reports where patient death was recorded as the worst outcome and 19,860 injury reports.⁶ Those numbers require context. MAUDE records death as the worst patient outcome without establishing that the device caused it, and Impella patients are already critically ill, often in cardiogenic shock with high baseline mortality.

The Recalls Behind the Claims

The lawsuits draw heavily on a string of FDA recalls, several carrying the agency’s most serious Class I designation.

March 2024 Class I Recall for Heart Wall Perforation

In March 2024, the FDA issued a Class I recall covering 66,390 Impella left-sided blood pumps distributed between October 2021 and October 2023. The recall was triggered by the risk that the pump catheter could perforate the wall of the left ventricle. At the time, the FDA had received reports of at least 129 serious injuries and 49 deaths linked to the devices.² The affected models included the Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.5 with SmartAssist, and Impella LD.⁴

Earlier Class I Recalls

A June 2023 Class I recall addressed the risk that the Impella motor housing could contact the stent of a transcatheter aortic valve replacement device in patients who had previously undergone valve surgery, destroying the pump’s impeller blades. Abiomed reported 30 complaints, 26 injuries, and four deaths tied to that issue.⁷

In April 2023, Abiomed issued a Class I recall for 466 Impella 5.5 with SmartAssist devices after purge fluid leaks from the pump’s sidearm caused pumps to stop. The company had received 179 complaints and three reported injuries. The root cause had been identified internally as early as 2019, and a technical bulletin on purge management was issued in April 2020, but the formal recall did not come until April 2023.⁸⁹

Recent Safety Alerts

December 2024: A Class I recall updated instructions for the Impella RP with SmartAssist and Impella RP Flex after finding that guidewires or other instruments could damage the pump’s optical sensor.¹⁰
July 2025: An FDA safety alert for Automated Impella Controllers linked to at least three patient deaths from device detection failures.²
August 2025: A recall of controllers containing incorrect capacitors in the pump driver circuit, with one death reported.¹¹
October 2025: A Class I recall targeting cybersecurity vulnerabilities in the Automated Impella Controller. No cyberattacks or patient harm had been reported.¹²
February 2026: An FDA warning regarding sensor problems linked to more than two dozen injuries.²
May–June 2026: An early alert flagged specific Impella CP with SmartAssist units that did not meet design specifications, causing low purge pressure. Three pump exchanges resulted in serious injuries and one death.¹³

The FDA Warning Letter

On September 19, 2023, the FDA sent Abiomed a formal warning letter following an inspection of the company’s Danvers, Massachusetts facility. The letter documented what the agency called “significant violations” across multiple areas of device regulation.¹⁴

The FDA found that internal corrective action for the purge sidearm leaks had been opened in February 2020 and classified as “Major” severity with “Extreme” occurrence, yet no health hazard evaluation or formal recall was initiated until FDA inspectors arrived three years later. The agency also found that Abiomed failed to report malfunctions and deaths within the required 30-day window and missed 10-day deadlines for submitting correction plans.¹⁵¹⁶ Separately, the letter cited Abiomed for marketing the Impella Connect remote-monitoring portal without premarket approval.

The warning letter’s documentation of delayed action forms a substantial part of the factual basis for the failure-to-warn and fraud claims in the pending lawsuits.

Where the Litigation Stands

The cases are in early procedural stages. There is no multidistrict litigation consolidation, no global settlement, and no trial dates have been set.¹

In August 2025, a judge found the pending class action was “not suitable” for settlement negotiations. Abiomed has filed a motion to dismiss the class action, which remains pending. In one individual wrongful death case, Abiomed filed an opposition to a plaintiff’s motion to amend his complaint, arguing that the device’s labeling already warned of hemolysis risks.¹

Because there is no consolidation, individual plaintiffs are filing their own suits in state and federal courts. The June 2025 proposed class covers injuries and deaths between January 2018 and March 2024, so patients or families with events in that window may fit within the class if it is certified. Whether an individual claim is stronger than joining a class depends on jurisdiction, the model of device involved, and the specific injury.

Who the Defendants Are

Abiomed was founded in 1981.¹⁷ Johnson & Johnson completed its acquisition of the company on December 22, 2022, paying $380 per share in cash — roughly $16.6 billion in total enterprise value — plus contingent payments of up to $35 per share tied to future commercial and clinical milestones.¹⁸ Abiomed now operates as a standalone business within J&J’s MedTech division.

The May 2025 class action names both Abiomed and Johnson & Johnson as defendants, and other complaints have followed the same approach.³

One Note on the Clinical Debate

The lawsuits sit against a longer-running debate about whether Impella devices actually improve survival in cardiogenic shock. The DanGer Shock randomized trial of 355 patients found lower 180-day mortality with Impella (45.8 percent versus 58.5 percent with standard care), but serious adverse events occurred at nearly four times the rate of the control group — 24 percent versus 6.2 percent — including severe bleeding, limb ischemia, hemolysis, and worsening aortic regurgitation. The trial’s lead investigator cautioned against extending the results beyond the specific patient population studied.¹⁹ Plaintiffs point to the gap between the device’s rapid adoption and the thinness of the underlying evidence as part of their failure-to-warn theory.

Anyone considering a claim should preserve their medical records, including the specific Impella model used, the lot or serial number if available, hospital records covering the procedure and its complications, and any communications from the hospital or manufacturer about recalls affecting the device they received. Statutes of limitations for product liability and wrongful death claims vary by state, so time-sensitive decisions turn on where the case would be filed.

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