Home / Recalls / Medical Devices
Cyberonics, Inc recalls VNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 Intended Use/Indications: United States Indications fo
Recalled February 14, 2018 · FDA recall Z-0555-2018 · Cyberonics
Hazard
Two Model 3000 Programmers were distributed in error by prior to FDA approval of version 1.0.2.2 software. · FDA Class II
Units
2 units
Sold at
US Distribution to the states of : CO and ND
Description
Two Model 3000 Programmers were distributed in error by prior to FDA approval of version 1.0.2.2 software.
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.
Manufacturer(s)
Cyberonics, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →