Z-1526-2015Class II

VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104; CYBERONICS, INC

Name: Z-1526-2015 VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104; CYBERONICS, INC
Creator: Cyberonics, Inc
Published: 2015-03-06
License: https://open.fda.gov/license/

LivaNova USA, Inc. / initiated 2015-03-06 / Terminated / root cause: manufacturing process

FDA source

Cyberonics, Inc began a recall of VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104; CYBERONICS, INC on 2015-03-06. FDA classified it as Class II and gives the reason as "The pulse generators have a lower battery longevity than specified in their design requirement as a result of the devices being inadvertently left in a programmed ON state during manufacture". 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-1526-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-06
Posted: 2015-04-27
Terminated: 2015-10-09
Recalling firm: LivaNova USA, Inc.
Product: VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104; CYBERONICS, INC.
Product code: LYJ Stimulator, Autonomic Nerve, Implanted For Epilepsy
Reason for recall: The pulse generators have a lower battery longevity than specified in their design requirement as a result of the devices being inadvertently left in a programmed ON state during manufacture.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 03/6/2015, the recalling firm sent a recall notification letter to their consignees. The letter included an effectiveness card which is to be signed by the consignee and returned to the recalling firm.
Quantity in commerce: 13 units
Distribution: AR, TX, GA, CA, MI, IN, FL, AZ, NV
Product codes and lots: Serial Numbers: 37627, 38473, 38539, 41446, 42887, 43491, 44186, 44339, 44391, 44443, 44455, 44510, 50715

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1526-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1526-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-06	2015-04-27

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)