ICD defibrillators risk reduced or absent therapy output from feedthrough defect
Certain ICD defibrillators may produce reduced or no energy output during high-voltage therapy due to a feedthrough defect. FDA Class I recall affects approximately 2,031 units nationwide and worldwide.
- Product
- ICD CROME VR MRI DF4, Model Number DVPC3D4; Implantable Cardioverter Defibrillators
- Category
- Medical Device
- Distribution
- Distributed nationwide