The FDA has issued a recall for two heart pumps, the HeartMate II and HeartMate 3, due to their association with hundreds of injuries and at least 14 deaths. Manufactured by Thoratec Corp., a subsidiary of Abbott Laboratories, these devices are used in patients with end-stage heart failure either as a bridge to transplantation or as a permanent solution. The recall, the most serious level, was prompted by concerns about the buildup of “biological material” in the pumps, reducing their effectiveness and potentially leading to life-threatening complications.
Despite surgeons noticing issues with these devices for years, the recall raises questions about the timely reporting of problems with approved medical devices. Abbott has communicated the risk to customers, but concerns linger about transparency and patient safety.
The FDA advises doctors to monitor patients for low-flow alarms indicating pump obstruction and to take appropriate action, which may include surgery to clear the blockage. This recall follows another earlier in the year related to the HeartMate 3’s communication system.
While the HeartMate 3 is currently the only option for many patients with end-stage heart failure, concerns about its safety and the potential lack of alternatives if it is removed from the market remain. Transparency from Abbott about efforts to address the issue is crucial for informed decision-making by both physicians and patients.