Most Recalled Cardiovascular Devices Lacked Clinical Testing
Most cardiovascular devices recalled between 2013 and 2022 lacked premarket clinical testing and postmarket surveillance, new research finds.
Most cardiovascular devices recalled between 2013 and 2022 lacked premarket clinical testing and postmarket surveillance, new research finds.
Medtronic has issued a Class I recall for certain implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators. The recall affects hundreds of thousands of devices with potential energy output issues during high voltage therapy.