United States – Two FDA-cleared lifesaving devices used by end-stage heart failure patients are now under the strictest U.S. Food and Drug Administration recall, citing concerns over safety.
Recall Details
The recall is linked to 273 reported injuries and 14 deaths associated with the HeartMate II and III devices, manufactured by Thoratec Corp., a subsidiary of Abbott Laboratories, as reported by HealthDay.
Device Description
The HeartMate II and III are crucial for both short- and long-term support in adult patients with severe left ventricular heart failure, providing vital assistance while awaiting a heart transplant or as a permanent solution when transplantation is not possible.
The devices may develop clots from biological material accumulation, obstructing blood flow and potentially leading to adverse events, including injury or death.
“This buildup can obstruct the device, making it less effective in helping the heart pump blood,” the FDA explained. “It can trigger alarms indicating low blood flow and affect the device’s ability to help the heart properly. The accumulation of biological material typically occurs over two years or more.”
Urgent Measures
Thoratec has issued an Urgent Medical Device Correction Letter to all affected customers, advising vigilance for low flow alarms, indicative of aortic valve obstruction.
Physicians are urged to closely monitor patients, consider stent implantation, or replace the pump if alerted by low flow alarms.
Research Findings
A study published in the Journal of Thoracic and Cardiovascular Surgery in 2022 reported blockages in 3% of patients receiving the devices, with the risk of obstruction expected to rise over time.
Specialists in cardiology express apprehension about the limited alternatives available if the HeartMate devices are withdrawn from the market, emphasizing the critical role these devices play in managing advanced heart failure, as reported by HealthDay.
Expert Insights
“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,” said Pagani, who also oversees a proprietary database of HeartMate II and HeartMate 3 implants.