FDA Recalls Medtronic Implantable Defibrillators Due to Potential Output Risk
Medtronic's ICD-VR VISIA AF S implantable defibrillators may fail to deliver energy during high-voltage therapy due to a feedthrough component defect. The FDA Class I recall affects 194 units distributed nationwide and worldwide.
- Product
- ICD-VR VISIA AF S US/OUS DF4, Model Number DVAC3D4; Implantable Cardioverter Defibrillators
- Category
- Medical Device
- Distribution
- Distributed nationwide