Heart devices linked to injuries, deaths receive FDA’s most serious recall

April 18, 2024 - In a recent announcement, the Food and Drug Administration (FDA) revealed that a pair of heart devices, the HeartMate II and HeartMate 3 Left Ventricular Assist System (LVAS), has received the agency's most serious recall classification due to long-term buildup and has been linked to hundreds of injuries and at least 14 deaths. The recall has raised concerns among safety advocates and healthcare professionals about the reporting and managing issues related to approved medical devices. 

Manufactured by Thoratec Corp., a subsidiary of Abbott Laboratories, the HeartMate 3 is recognized as the safest mechanical heart pump in its category. However, a federal database containing over 4,500 reports suggests that this medical device may have caused or contributed to patient deaths. The recall comes years after surgeons initially observed problems with the HeartMate II and HeartMate 3 LVAS. 

Despite the recall, the devices are not being removed from the market. According to an email response from Abbott Laboratories, the company has communicated the risk to its customers this year. This delayed action has prompted questions from safety advocates regarding reporting and disclosing issues associated with approved medical devices.  

There have been thousands of reports of patient injuries and deaths associated with these heart devices. 

Cardiothoracic surgeon Francis Pagani, MD, from the University of Michigan, expressed concern about the potential consequences of losing the HeartMate devices to KFF Health News, saying, "While acknowledging that the devices are not perfect, they are currently the best available option.” 

Cardiologist Sanket Dhruva, MD, MHS, an expert in medical device safety and regulation at the University of California-San Francisco, also shared his concerns with KFF Health News about the lack of public awareness surrounding these issues. While some surgeons might have been aware of the problems, others — particularly those who infrequently implant the devices — may have been unaware, leading to adverse patient events. 

The recall affects nearly 14,000 HeartMate devices, consisting of mechanical pumps that assist the heart in circulating blood when it cannot do so independently. These small devices are implanted in patients with end-stage heart failure who are awaiting a heart transplant or as a permanent solution for those ineligible for transplantation. 

According to the FDA's recall notice, the devices can develop a buildup of "biological material" over time, reducing their ability to circulate blood effectively and potentially endangering patients' lives. Physicians have been advised to monitor patients for low-flow alarms that indicate obstruction and to take appropriate action, such as surgery to implant a stent, release the blockage, or replace the pump. 

"The rates of outflow obstruction are low, and patients with normally functioning devices have no cause for concern," Justin Paquette, a spokesperson for Abbott Laboratories, the manufacturer of the HeartMate devices, told KFF Health News in an email. 

FDA press officer Amanda Hils told KFF Health News that the agency is collaborating with Abbott to investigate the reported injuries and deaths and determine if further action is necessary. The number of deaths reported thus far appears consistent with the adverse events observed during the initial clinical trial of the HeartMate devices. 

This is the second Class 1 recall of a HeartMate device in 2024.

In January, Abbott issued an urgent correction letter regarding a separate issue in which the HeartMate 3 unintentionally starts and stops due to a communication system malfunction. The FDA alerted the public to this issue in March. Abbott also issued an urgent letter to hospitals in February regarding the blockage problem, urging physicians to monitor patients for low-flow alarms. 

A study published in the Journal of Thoracic and Cardiovascular Surgery in 2022 reported obstructions in approximately 3% of cases, with a higher incidence rate observed over longer durations of device use. The only other Class 1 recall for the HeartMate 3 occurred in May 2018, involving a warning about the potential twisting and cessation of blood flow caused by a graft line. 

The FDA's recall notice provides additional guidance for physicians to diagnose blockages using an algorithm and, if necessary, perform a CT angiogram to verify the cause of the obstruction. 

The HeartMate 3, approved by the FDA in 2017, currently serves as the only medical option for many patients with end-stage heart failure who are ineligible for transplantation. If the recall leads to the device's removal from the market, these patients would be left without alternatives. 

Due to proprietary information, the precise number of patients who have received HeartMate II or HeartMate 3 implants is unknown. However, the FDA recall notices indicate that over 22,000 HeartMate 3 devices and more than 2,200 HeartMate II devices have been distributed worldwide. 

The delayed reporting of the blockage complication may be attributed, in part, to the absence of a mandate for physicians to report adverse events to federal regulators. Only device manufacturers, importers, and hospitals are required to report such events. 

Given this FDA recall classification, the healthcare technology community faces critical questions about the safety and reporting mechanisms surrounding approved medical devices. The injuries and deaths linked to these heart devices underscore the imperative for transparent and timely communication between manufacturers, healthcare providers, and regulatory agencies.  

While these devices have been pivotal in treating end-stage heart failure, the recall highlights the need for ongoing vigilance and scrutiny to ensure patient safety. As the healthcare community navigates the complexities of managing such incidents, a collective effort is essential to mitigate risks, enhance reporting protocols, and prioritize patient well-being.