RELIANCE 4-FRONT defibrillation leads recalled over rising LVSI measurements and coil calcification
RELIANCE 4-FRONT defibrillation leads are recalled because affected models may show gradually rising LVSI measurements linked to calcification of the defibrillation coils, which may lead to early lead replacement.
- Product
- RELIANCE 4-FRONT, endocardial cardioversion/defibrillation and pace/sense lead, Permanent Defibrillator Electrodes; Model Nos. 0654, 0655, 0657, 0658, 0682, 0683, 0685, 0686, 0692, 0693, 0695, 0696
- Category
- Medical Device
- Distribution
- Distributed nationwide