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FDAAugust 13, 2019device

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)

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

livanova

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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