LivaNova USA Inc recalls VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800 Model 1000 Generator Sample Labels 26-0009-9600 Patien…

Recall date

August 13, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1118-2020

FDA classification

Class II

Brand / firm

LivaNova USA Inc

Sold / distributed

US: FL, GA, KS, MO, and UT. No OUS distribution

Why it was recalled

Firm identified a subset of its generators that were sterilized one additional sterilization cycle, which does not meet the firm's quality specifications.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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)