Z-0555-2018Class II

VNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 Intended Use/Indications: United States...

Name: Z-0555-2018 VNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 Intended Use/Indications: United States...
Creator: Cyberonics, Inc
Published: 2017-12-02
License: https://open.fda.gov/license/

LivaNova USA, Inc. / initiated 2017-12-02 / Terminated / root cause: manufacturing process

FDA source

Cyberonics, Inc began a recall of VNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 Intended Use/Indications: United States Indications for Use: Epilepsy : The VNS Therapy System is... on 2017-12-02. FDA classified it as Class II and gives the reason as "Two Model 3000 Programmers were distributed in error by prior to FDA approval of version 1.0.2.2 software". 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-0555-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-02
Posted: 2018-02-08
Terminated: 2018-08-06
Recalling firm: LivaNova USA, Inc.
Product: VNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 Intended Use/Indications: United States Indications for Use: Epilepsy : The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients 4 years of age and older with partial onset seizures that are refractory to antiepileptic medications. Depression : VNS Therapy is indicated for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments.
Product code: LYJ Stimulator, Autonomic Nerve, Implanted For Epilepsy
Reason for recall: Two Model 3000 Programmers were distributed in error by prior to FDA approval of version 1.0.2.2 software.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The units were collected by visit on December 21, 2017 and December 28, 2017 from the physicians. Both programmers have been successfully removed from the customers and no further actions are being proposed. For further questions, please call (281) 228-7260.
Quantity in commerce: 2 units
Distribution: US Distribution to the states of : CO and ND
Product codes and lots: Part Number: 10-0011-0500 Serial number/UDI: 8LYB7F2/010542502575039911170920218LYB7F29910-0011-0500 D80C7F2/01054250257503991117092921D80C7F29910-0011-0500

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0555-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0555-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-14	2018-02-08

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)