The recall includes devices distributed between Oct. 13, 2017, and June 9, 2023.
The implantable defibrillators detect and treat irregular heartbeats by producing an electric shock, but if that shock underperforms or does not happen, the malfunction “can lead to cardiac arrest, other serious injury or death,” according to the FDA.
As of July 18, there have been 28 complaints, 22 injuries and zero deaths reported.
Medtronic told providers in May to not prophylactically replace devices and reprogram the high voltage therapy pathways.
