What you should know about recalls of cardiac devices

Implanted heart devices include pacemakers and implantable cardioverter defibrillators (ICDs), which monitor and correct abnormal heart rhythms. While very reliable, they are not perfect, and recalls of these devices affect thousands of people each year, according to a 2024 study. Testing the effectiveness and safety of cardiac devices is far more complicated than testing drugs. But efforts are under way to improve postmarket tracking of device complications by using electronic health records, Medicare databases, and registries developed in partnership with device manufacturers.