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

Recall date

December 2, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0555-2018

FDA classification

Class II

Brand / firm

Cyberonics, Inc

Sold / distributed

US Distribution to the states of : CO and ND

Why it was recalled

Two Model 3000 Programmers were distributed in error by prior to FDA approval of version 1.0.2.2 software.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.