In a sweeping safety alert, the FDA has demanded a recall of heart pump devices manufactured by Abbott Laboratories' subsidiary Thoratec Corp after they were linked to numerous injuries and fatalities. At the heart of the issue are the HeartMate II and HeartMate 3 devices, which the FDA classified under their most severe recall level following reports of 273 injuries and 14 deaths associated with the pumps. These left ventricular assist systems are vital for patients with serious heart conditions, acting as a mechanical aid for the heart to circulate blood.
The FDA's drastic measure comes after revelations that these devices might accumulate "biological material" over time, potentially causing obstruction and failure to pump blood effectively. This accumulation is found to happen typically over a span of two years or more, making it a potentially serious long-term complication for patients reliant on the device for survival. The FDA emphasizes the gravity of the situation, noting on their website, that the use of affected heart pumps "may cause serious adverse health consequences and in worst cases, could result in death."
Both the HeartMate II and its successor, the HeartMate 3, designed for adults and even children in the latter's case, have been in use since April 21, 2008. Since then, these devices have become integral to the management of end-stage heart failure. With nearly 14,000 devices impacted by the recall, much is at stake for the patients dependent on them. Thoratec Corporation has urged patients to be vigilant of low flow alarms, which may indicate the onset of significant blockage, as reported by NEXSTAR.
Physicians have been encouraged to diagnose potential blockages and monitor patients closely. Doctors have been guided by algorithm-based diagnoses or CT angiograms, as per the FDA's updated recall notice issued on April 15. Detailing the additional steps in an Urgent Medical Device Correction Letter, Thoratec Corporation reached out to affected patients on Feb. 19, 2024, requesting the return of acknowledgment forms so they can be updated routinely until corrective measures are fully implemented. As the situation develops, concerned customers can call the company at (844) 692-6367 for further information.
Investigations by the FDA are ongoing in collaboration with Abbott to assess the full extent of the reported injuries and deaths, and to determine whether more rigorous actions are warranted. According to the Chicago Sun-Times, FDA press officer Amanda Hils said the agency will keep working with Abbott to investigate the matters thoroughly. Meanwhile, physicians like Dr. Francis Pagani of the University of Michigan worry about the severe impact on patient care, stating to the Chicago Sun-Times, "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."
