Implantable Cardiac Devices Risk Therapy Failure From Feedthrough Defect
Certain Medtronic implantable cardioverter defibrillators may fail to deliver high-voltage therapy due to a defective feedthrough component. The FDA classified this as a Class I recall affecting 2,884 devices.
- Product
- CRTD COBALT HF MRI IS1 DF1, Model Number DTPB2D1; Implantable Cardioverter Defibrillators
- Category
- Medical Device
- Distribution
- Distributed nationwide