medical Class II Updated 2020-02-19

LivaNova USA Inc recalls VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-

Recalled 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)

Hazard / Issue

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

Issued by

FDA

Affected States: FL, GA, KS, MO, UT
Lot/Code Info: Model Serial No. UDI Model 1000 204460 01054250257504051119080317201205212044609910-0011-6102 Model 1000 183960 01054250257504051119080217200912211839609910-0011-6102 Model 1000 194980 01054250257504051119080217201030211949809910-0011-6102 Model 1000 204700 01054250257504051119080217201205212047009910-0011-6102 Model 1000 206720 01054250257504051119080317201219212067209910-0011-6102 Model 1000 213290 01054250257504051119080517210108212132909910-0011-6102
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