Recall Z-0555-2018 ยท LYJ Stimulator, Autonomic Nerve, Implanted For Epilepsy
Cyberonics, Inc
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 t
| Date | Dec 2, 2017 |
| Status | Terminated |
| Reason | Two Model 3000 Programmers were distributed in error by prior to FDA approval of version 1.0.2.2 software. |
| 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 | 2 units |
| Distribution | US Distribution to the states of : CO and ND |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.