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LivaNova USA Inc recalls VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800 Model 1000 Generator Sample Labels 26-0009-9600 P
Recalled February 19, 2020 · FDA recall Z-1118-2020 · LivaNova USA
Hazard
Firm identified a subset of its generators that were sterilized one additional sterilization cycle, which does not meet the firm's quality specifications. · FDA Class II
Units
6 generators
Sold at
US: FL, GA, KS, MO, and UT. No OUS distribution
Description
Firm identified a subset of its generators that were sterilized one additional sterilization cycle, which does not meet the firm's 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)
Manufacturer(s)
LivaNova USA Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →