A pair of heart devices linked to hundreds of injuries and at least 14 deaths has received the FDA’s most serious recall, the agency announced Monday.

The recall comes years after surgeons say they first noticed problems with the HeartMate II and HeartMate 3, manufactured by Thoratec Corp., a subsidiary of Abbott Laboratories. The devices are not currently being removed from the market. In an emailed response, Abbott said it had communicated the risk to customers this year.

The delayed action raises questions for some safety advocates about how and when issues with approved medical devices should be reported. The heart devices in question have been associated with thousands of reports of patients’ injuries and deaths, as described in a KFF Health News investigation late last year.

“Why doesn’t the public know?” said Sanket Dhruva, a cardiologist and an expert in medical device safety and regulation at the University of California-San Francisco. Though some surgeons may have been aware of issues, others, particularly those who do not implant the device frequently, may have been in the dark. “And their patients are suffering adverse events,” he said.

The recall involves a pair of mechanical pumps that help the heart pump blood when it can’t do so on its own. The devices, small enough to fit in the palm of a hand, are implanted in patients with end-stage heart failure who are waiting for a transplant or as a permanent solution when a transplant is not an option. The recall affects nearly 14,000 devices.

Amanda Hils, an FDA press officer, said the agency is working with Abbott to investigate the reported injuries and deaths and determine if further action is needed.

“To date, the number of deaths reported appears consistent with the adverse events observed in the initial clinical trial,” Hils said in an email.

According to the FDA’s recall notice, the devices can cause buildup of “biological material” that reduces their ability to help the heart circulate blood and keep patients alive. The buildup accumulates gradually and can appear two years or more after a device is implanted in a patient’s chest.

Doctors were advised to watch out for “low-flow alarms” on the devices and, if they do diagnose the obstruction, to either monitor the patient or perform surgery to implant a stent, release the blockage, or replace the pump. “Rates of outflow obstruction are low,” Abbott spokesperson Justin Paquette said in an email, adding that patients whose devices are functioning normally “have no reason for concern.”

A review of the FDA device database shows at least 130 reports related to HeartMate II or 3 that mention the complication reported by regulators. The earliest such report filed with the FDA dates to at least 2020, according to a KFF Health News review of the database.

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