Z-1118-2020Class II

VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800 Model 1000 Generator Sample Labels...

Name: Z-1118-2020 VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800 Model 1000 Generator Sample Labels...
Creator: LivaNova USA Inc
Published: 2019-08-13
License: https://open.fda.gov/license/

LivaNova USA, Inc. / initiated 2019-08-13 / Terminated / root cause: manufacturing process

FDA source

LivaNova USA Inc began a recall of 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... on 2019-08-13. FDA classified it as Class II and gives the reason as "Firm identified a subset of its generators that were sterilized one additional sterilization cycle, which does not meet the firm's quality specifications". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1118-2020
Classification: Class II
Status: Terminated
Initiated: 2019-08-13
Posted: 2020-02-10
Terminated: 2022-05-18
Recalling firm: LivaNova USA, Inc.
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)
Product code: LYJ Stimulator, Autonomic Nerve, Implanted For Epilepsy
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.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 6 generators
Distribution: US: FL, GA, KS, MO, and UT. No OUS distribution
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1118-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1118-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-10

Product code LYJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)