Implantable cardioverter defibrillators may output reduced or no energy during therapy
Medtronic ICDs and CRT-Ds with specific feedthroughs may fail to deliver adequate high-voltage therapy. This FDA Class I recall affects 487 units distributed nationwide and worldwide.
- Product
- ICD CROME DR MRI IS1 DF1, Model Number DDPC3D1; Implantable Cardioverter Defibrillators
- Category
- Medical Device
- Distribution
- Distributed nationwide