Abbott Trifecta Heart Valve Lawsuit Filed Over Device Failure, Removal

Manufacturer recalled Trifecta heart valve from the market in July 2023, after the devices were linked to nearly 200 patient deaths caused by early structural valve deterioration (SVD) and device failures.

A Kentucky man has filed a lawsuit alleging that defects in his Trifecta heart valve forced him to undergo replacement surgery, which he claims the manufacturer knew, or should have known about before he was implanted with the device.

The complaint (PDF) was originally brought by Ronald Luckey in Kentucky Circuit Court on September 16, 2025, naming Abbott Laboratories Inc. as the sole defendant. However, the case was removed to the U.S. Federal District Court for the Eastern District of Kentucky on October 20. 

Abbott Trifecta Heart Valve Recall & Warnings

Abbott Laboratories is the manufacturer of the Trifecta Heart Valve, a kind of prosthetic designed to treat individuals with diseased, damaged or malfunctioning aortic heart valves, which control the flow of oxygen-rich blood from the heart to the rest of the body.

Trifecta heart valves were originally approved by the U.S. Food and Drug Administration (FDA) in 2011, with newer Trifecta GT models gaining approval in 2016. 

On July 31, 2023, all Trifecta heart valves were recalled from the U.S. market due to concerns about early structural valve deterioration (SVD). Federal health officials warned that the devices showed a higher rate of early SVD compared to other commercially available replacement valves.

The agency indicated that between 2011 and 2023, nearly 3,000 adverse event reports were linked to Trifecta heart valves, including more than 2,100 injuries and at least 191 deaths.

The recall came nearly six months after the FDA first posted about the potential for Abbott Trifecta valve deterioration risks. Individuals with the device were advised to seek immediate medical attention if they experienced shortness of breath, fatigue or other new symptoms linked to signs of early valve deterioration (SVD), which is a problem that can affect artificial heart valves, causing them to narrow, leak, or both, often leading to surgical replacement, medical intervention, or even death.

Abbott Trifecta Heart Valve Failure Lawsuit

In his lawsuit, Luckey claims that he was implanted with an Abbott Trifecta GT heart valve in January 2017, which was expected to last 10 to 15 years.

However, the complaint points out that the FDA issued a Letter to Health Care Providers in February 2023, indicating that many Trifecta heart valves suffered from SVD within five years of implantation. Within six months of this letter, Abbott announced that it was discontinuing all Trifecta heart valves, including the GT model, on July 31, 2023.

In September 2024, doctors determined that Luckey’s Trifecta heart valve had experienced structural valve deterioration (SVD), prompting its removal and replacement seven years after implantation. The complication led to further surgery and significant ongoing medical treatment.

The lawsuit indicates that Abbott should have known Trifecta valves were prone to early SVD prior to the GT valve’s premarket approval in 2016, yet failed to report this defect to the FDA, in violation of multiple federal regulations, including those covering medical device reporting (21 CFR 803), premarket approval requirements (21 CFR 814) and quality-system regulations (21 CFR 820), which require the manufacturer to promptly disclose known device defects and performance problems to the FDA.

“Upon information and belief, Abbott knew or should have known from available clinical data that the Trifecta valve was prone to early SVD prior to and after its pre-market approval in 2016 yet failed to report the defect to the FDA or withdraw the product until 2023, in violation of the Federal Regulations.”

— Ronald Luckey v. Abbott Laboratories Inc.

Luckey raises allegations of strict liability, negligence, breach of warranty and failure to warn against Abbott. He is seeking compensation for medical expenses, lost income, diminished earning capacity and ongoing pain and suffering related to the replacement surgery.

Abbott requested the case be moved to federal court on October 20, noting that the company is incorporated in Delaware and headquartered in Illinois, which establishes diversity jurisdiction, and that the amount in controversy exceeds $75,000, which is the jurisdictional limit of the Kentucky Circuit Court.

Heart Valve Replacement Lawsuit Investigations

Since the manufacturer removed the product from the market, attorneys have been investigating potential Trifecta heart valve lawsuits for individuals who received a Trifecta or Trifecta GT valve and later experienced early deterioration, revision or replacement surgery, serious complications, or wrongful death.

Individuals who experienced complications from a failed Trifecta heart valve may be eligible to pursue financial compensation through a lawsuit. Consultations are free, and no fees or costs are charged unless a recovery is obtained.

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