LivaNova Recalls Six VNS Therapy SENTIVA Generators for Sterilization Error
LivaNova USA Inc is recalling six VNS Therapy SENTIVA Generator Model 1000 units because they were sterilized one additional cycle, failing to meet quality specifications.
- Product
- VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800 Model 1000 Generator Sample Labels 26-0009-9600 Patient s Manual for Depression 26-0009-9500 Patient s Manual for Epilepsy 76-0000-5000 VNS Therapy System Physician s Manual (refer to Attachment 1)
- Category
- Medical Device
- Distribution
- 5 states