The FDA stated on Monday that two heart devices that have been connected to hundreds of injuries and at least 14 deaths have become the subject of its most serious recall.

Years have passed since surgeons claim they first became aware of issues with Thoratec Corp.’s (an Abbott Laboratories subsidiary) HeartMate II and HeartMate 3 devices. At this time, the gadgets are not being taken off the market. KFF Health News reached out to Abbott for comment, but Abbott did not answer.

Some safety advocates are concerned about when and how to disclose problems with approved medical devices in light of the delayed response. A late-year KFF Health News investigation detailed how thousands of reports of patient injuries and fatalities have been linked to the aforementioned heart devices.

“Why doesn’t the public know?” remarked Sanket Dhruva, a cardiologist at the University of California, San Francisco who specializes in medical device safety and regulation. While some surgeons could have known of problems, others might not have, especially those who don’t use the device frequently. “And their patients are suffering adverse events,” he stated.

Two mechanical pumps that assist the heart in pumping blood when it is unable to do so on its own are the subject of the recall. The devices are implanted in patients with end-stage heart failure who are awaiting a transplant or as a permanent fix in cases when a transplant is not an option. They are small enough to fit in the palm of a hand. Over 13,000 gadgets are included in the recall.

According to FDA press officer Amanda Hils, the agency is collaborating with Abbott to look into the reported injuries and deaths and decide whether to take additional action.”To date, the number of deaths reported appears consistent with the adverse events observed in the initial clinical trial,” Hils wrote in his email.

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

The devices may result in the accumulation of “biological material,” which lessens their capacity to aid in blood circulation and maintain patient survival, according to the FDA’s recall notice. The accumulation happens gradually and may show up up to two years following the implantation of a device in the chest of a patient.

Physicians were instructed to keep an eye out for “low-flow alarms” on the devices and, in the event that they identify an obstruction, to monitor the patient or operate to replace the pump, remove the blockage, or insert a stent.

According to an examination of the FDA device database, HeartMate II or 3 is mentioned in at least 130 reports that address the issue that authorities have reported. A examination of the database by KFF Health News indicates that the earliest report of this type that was submitted to the FDA is from at least 2020.

This year’s second Class 1 recall involving a HeartMate device occurred on Monday.

Regarding a different problem, Abbott sent an urgent “correction letter” to hospitals in January. The HeartMate 3 inadvertently starts and stops because of the pump’s communication system, which cardiologists use to evaluate patients’ conditions. In March, the FDA notified the public.

Abbott sent out another urgent letter to hospitals in February regarding the blockage issue, requesting that they notify doctors, fill out and send an acknowledgment form, and keep an eye out for low-flow alerts on the device’s monitor that might point to an obstruction. In the letter, the corporation stated that it is developing “a design solution” to stop the obstructions.

About 3% of instances suffered obstruction, according to a 2022 study published in the Journal of Thoracic and Cardiovascular Surgery; nevertheless, the occurrence rate increased with the length of time a patient had the device.

The only other Class 1 recall for the HeartMate 3 occurred in May 2018, when hospitals and doctors received corrective action notifications from the firm alerting them to the possibility that blood flow could be interrupted by a twist in the graft line that transports blood from the pump to the aorta.

Additional instructions for doctors to identify the blockage using an algorithm to find obstructions and, if necessary, a CT angiography to confirm the reason are included in the FDA recall notice that was released on Monday.

For many patients with end-stage heart failure who do not meet the criteria for a transplant, the HeartMate 3, which was initially approved by the FDA in 2017, is currently their last available medical alternative. The HeartMate II, approved by the FDA in 2008, has been replaced by the HeartMate 3.
Patients with end-stage heart failure may be left with no options if the device is taken off the market as a result of the latest recall, according to Francis Pagani, a cardiothoracic surgeon at the University of Michigan who also manages a confidential database of HeartMate II and HeartMate 3 implants.

“We are in trouble,” warned Pagani, if that occurs. “Not having this option would be disastrous for the patients. Although no pump is ever perfect, this is the best choice available.”

The exact number of patients who have gotten an implanted HeartMate II or HeartMate 3 is unknown. That data is confidential. More than 22,000 HeartMate 3 devices and more than 2,200 HeartMate II devices are distributed globally, according to FDA recall warnings.

According to Madris Kinard, the founder of Device Events, a company that makes FDA device data more accessible to hospitals, legal firms, and investors, and a former FDA medical device official, the blockage complication may not have been brought to the public’s attention for as long because physicians are not obligated to report adverse events to federal regulators.

Laws only require hospitals, device importers, and manufacturers to notify the FDA of major malfunctions, fatalities, and injuries related to their products.

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

The physician, Dhruva, stated that in order for him to have more in-depth discussions with patients who are thinking about getting a HeartMate device, he is expecting Abbott to be transparent about the steps the business is taking to remedy the issue.

“We anticipate having some data that states, ‘Hey, we made this patch, and this fix works, and it doesn’t generate a new issue.’ I’m interested in knowing that,” he remarked. “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.”