Medtronic recalls 348K implantable heart devices over safety concerns

Medtronic is recalling nearly 350,000 implantable cardiac devices, including implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), due to issues with their ability to deliver high voltage therapy. The FDA has categorized this as a Class I recall, as the devices may cause serious injuries or death. There have been 22 injuries reported so far, but no deaths. Medtronic previously recalled 87,709 devices in August 2022 for a similar issue. Customers have been advised not to replace devices proactively and to follow specific programming instructions.