Z-1591-2010

VNS Therapy Demipulse Generator, Model 103 and VNS Therapy Demipulse Duo Generator, Model 104 VNS Therapy...

Name: Z-1591-2010 VNS Therapy Demipulse Generator, Model 103 and VNS Therapy Demipulse Duo Generator, Model 104 VNS Therapy...
Creator: Cyberonics, Inc
Published: 2010-04-06
License: https://open.fda.gov/license/

LivaNova USA, Inc. / initiated 2010-04-06 / Terminated / root cause: software

FDA source

Cyberonics, Inc began a recall of VNS Therapy Demipulse Generator, Model 103 and VNS Therapy Demipulse Duo Generator, Model 104 VNS Therapy Programming System, Model 250 Version 7.0 and 7.1... on 2010-04-06. The reason FDA records is "Battery life projection is inaccurate". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1591-2010
Status: Terminated
Initiated: 2010-04-06
Posted: 2010-05-10
Terminated: 2012-08-20
Recalling firm: LivaNova USA, Inc.
Product: VNS Therapy Demipulse Generator, Model 103 and VNS Therapy Demipulse Duo Generator, Model 104 VNS Therapy Programming System, Model 250 Version 7.0 and 7.1 Software
Product code: LYJ Stimulator, Autonomic Nerve, Implanted For Epilepsy
Reason for recall: Battery life projection is inaccurate.
Root cause tag: software
FDA root cause: Software design
Action: Safety Alert sent April 6, 2010 to all physicians of record for Model 103 or Model 104 generators and to all hospitals with non-implanted affected product, that explains the event, risks presented and recommended actions to take. The generator can be reprogrammed by the physician the next time the patient is seen in the clinic. The issue can also be corrected during the initial implant procedure with the instructions provided. Additional questions should be directed to the firm; United States customers can contact Clinical Technical Support at 866-882-8804.
Quantity in commerce: Model103: 8109 units; Model 104: 1722 units; Programmers: 8891
Distribution: Worldwide distribution.
Product codes and lots: Model 103, VNS Therapy Demipulse Generator Model 104, VNS Therapy Demipulse Duo Generator Model 250, Programming System (version 7.0 or 7.1)

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)