FDA announces recall of heart pumps linked to deaths and injuries

Monday’s alert is the second Class 1 recall of a HeartMate device this year.

In January, Abbott issued an urgent “correction letter” to hospitals about a separate issue in which the HeartMate 3 unintentionally starts and stops due to the pump’s communication system, which cardiologists use to assess patients’ status. The FDA alerted the public in March.

In February, Abbott issued another urgent letter to hospitals about the blockage problem, asking them to inform physicians, complete and return an acknowledgment form, and pay attention to low-flow alarms on the device’s monitor that may indicate an obstruction. The company said in the letter that it is working on “a design solution” to prevent the blockages.

A study published in 2022 in the Journal of Thoracic and Cardiovascular Surgery reported the obstruction in about 3% of cases, though the incidence rate was higher the longer a patient had the device.

The only other Class 1 recall issued for the HeartMate 3 was in May 2018, when the company issued corrective action notices to hospitals and physicians warning that the graft line that carries blood from the pump to the aorta could twist and stop blood flow.

The FDA recall notice issued Monday includes additional guidance for physicians to diagnose the blockage using an algorithm to detect obstructions and, if needed, a CT angiogram to verify the cause.

At present, the HeartMate 3, which was first approved by the FDA in 2017, is the only medical option for many patients with end-stage heart failure and who do not qualify for a transplant. The HeartMate 3 has supplanted the HeartMate II, which received FDA approval in 2008.

If the new recall leads to the device being removed from the market, end-stage heart failure patients could have no options, said Francis Pagani, a cardiothoracic surgeon at the University of Michigan who also oversees a proprietary database of HeartMate II and HeartMate 3 implants.

If that happens, “we are in trouble,” Pagani said. “It would be devastating to the patients to not have this option. It’s not a perfect option — no pump ever is — but this is as good as it’s ever been.”

It’s not known precisely how many patients have received a HeartMate II or HeartMate 3 implant. That information is proprietary. The FDA recall notices show worldwide distribution of more than 22,000 HeartMate 3 devices and more than 2,200 of the HeartMate II.

The blockage complication may have gone unreported to the public for so long partly because physicians are not required to report adverse events to federal regulators, said Madris Kinard, a former FDA medical device official and founder of Device Events, a company that makes FDA device data more user-friendly for hospitals, law firms, and investors.

Only device manufacturers, device importers, and hospitals are required by law to report device-related injuries, deaths, and significant malfunctions to the FDA.

“If this is something physicians were aware of, but they weren’t mandated to report to the FDA,” Kinard said, “at what point does that communication between those two groups need to happen?”

Dhruva, the cardiologist, said he is looking for transparency from Abbott about what the company is doing to address the problem so he can have more thorough conversations with patients considering a HeartMate device.

“We’re going to expect to have some data saying, ‘Hey we created this fix, and this fix works, and it doesn’t cause a new problem.’ That’s what I want to know,” he said. “There’s just a ton more that I feel in the dark about, to be honest, and I’m sure that patients and their families do as well.”