Abbott Recalls Trifecta Heart Valves From U.S. Market Amid Concerns About Early Deterioration Problems

Following an FDA warning issued earlier this year about early deterioration problems with Trifecta heart valves, which have been linked to nearly 200 patient deaths since 2011, Abbott Laboratories has announced that it is removing the controversial valves from the market and recalling any remaining devices that medical providers still have in inventory.

In a letter (PDF) sent to customers on July 31, Abbott announced that it is discontinuing the Trifecta family of values, including the Abbott Trifecta Valve and the Trifecta Valve with Glide Technology (Trifecta GT). The manufacturer also indicated that it will collect unused devices from the field.

The recall comes nearly six months after the FDA first posted information about potential Abbott Trifecta Valve deterioration risks, urging individuals with the device to seek immediate medical attention if they experience shortness of breath, fatigue or other new symptoms. In addition, doctors were asked to ensure life-long follow up visits are conducted, at least once per year, to monitor for signs of early structural valve deterioration (SVD).

Trifecta Heart Valve Premature Deterioration Problems

The first generation model of the Trifecta valve was approved by the FDA in 2011, and the Trifecta GT valve was introduced in 2016. The valves are a type of prosthetic designed to treat individuals with diseased, damaged, or malfunctioning aortic heart valves, which play a crucial in the circulatory system, controlling the flow of oxygen-rich blood from the heart to the rest of the body.

In certain conditions, such as aortic stenosis (a narrowing of the aortic valve opening) or aortic regurgitation (a condition where the aortic valve doesn’t close tightly), the aortic valve does not function properly. For these individuals, doctors may recommend removing the patient’s original aortic valve and replacing it with a prosthetic.

Although the Trifecta valves were marketed as safe and effective, the devices have been associated with nearly 3,000 adverse events since 2011, including over 2,100 reported injuries and, 191 deaths.

These problems led the FDA to issue warnings to healthcare providers in February 2023, citing recent data that suggested the Trifecta valves are at risk of deteriorating within five years, with most problems appearing between three and four years after being implanted.

SVD is a known problem which can affect artificial heart valves, causing the aortic valve to narrow leak, or both, often leading to the need for further surgery. However, the FDA warned that the Trifecta valve deterioration rate, and the need for surgical intervention, was much higher than other heart valves on the market.

Abbott Trifecta Valve Recall Could Have Come Earlier

In the letter sent to customers this week, Abbott indicates that it decided to discontinue the Trifecta valves to focus on tissue heart valve solutions that maximize the possibility for lifetime management of valvular heart disease. However, the manufacturer may now faces serious questions about why it failed to issue a Trifecta valve recall earlier, or adequately disclose information about the early deterioration as soon as it was discovered.

The same day Abbott asked customers to remove unused devices, the FDA posted an update on it’s website, indicating that the agency’s recommendations for individuals implanted with a Trifecta valve has not changed. However, the FDA noted that it will continue to work with Abbott to evaluate the risk of early structural valve deterioration with devices already implanted, and keep the public informed if there are any new recommendations or regulatory actions.

The affected Trifecta valves and model numbers include; TrifectaTM Valve and TrifectaTM Valve with Glide Technology Model: TF-19A, TF-21A, TF-23A, TF-25A, TF-27A, TF-29A, TFGT-19A, TFGT-21A, TFGT-23A, TFGT-25A, TFGT-27A, and TFGT-29A.

In the coming weeks, the FDA may decide to classify the voluntary market withdrawal as an Abbott Trifecta Heart Valve recall, to make sure the public and healthcare providers understand the potential risks that may result from continued use of the devices.

Given the widespread problems linked to the device in recent years, it is also possible the manufacturer will face substantial liability from Abbott Trifecta Heart Valve lawsuits brought on behalf of individuals who experienced complications following early deterioration of the valve.