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)
FDA Recall Z-1118-2020 · Posted None
Recalling FirmLivaNova USA Inc
Recall StatusTerminated
Product CodeLYJ
Date Initiated2019-08-13
Date Terminated2022-05-18
Product Quantity6 generators
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.
Firm Action
On 08/13/2019, the firm contacted via telephone hospitals/facilities of the immediate need to remove and replace the affected devices. Reference Firm email communication dated 1/27/2020.
On 08/30/2019, prescribing physicians were telephone call with a follow-up email recommending replacement of the generators during an already planned or unrelated lead replacement surgery.
Root Cause
Process control
Distribution Pattern
US: FL, GA, KS, MO, and UT. No OUS distribution
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.