Recall Z-1118-2020— LivaNova USA Inc
Class II · Terminated
Class II FDA medical device recall by LivaNova USA Inc, initiated 2019-08-13, terminated 2022-05-18. FDA's recall record names no specific 510(k) clearance for this event. 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). Reason: Firm identified a subset of its generators that were sterilized one additional sterilization cycle, which does not meet the firm's quality specifications..
- Recalling firm
- LivaNova USA Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-08-13
- Terminated
- 2022-05-18
- Firm location
- Houston, TX, United States
Product description
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)
Reason for recall
Firm identified a subset of its generators that were sterilized one additional sterilization cycle, which does not meet the firm's quality specifications.
Data sourced from openFDA. This site is unofficial and independent of the FDA.