Recall Z-0555-2018— Cyberonics, Inc
Class II · Terminated
Class II FDA medical device recall by Cyberonics, Inc, initiated 2017-12-02, terminated 2018-08-06. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Two Model 3000 Programmers were distributed in error by prior to FDA approval of version 1.0.2.2 software..
- Recalling firm
- Cyberonics, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-12-02
- Terminated
- 2018-08-06
- Firm location
- Houston, TX, United States
Product description
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.
Reason for recall
Two Model 3000 Programmers were distributed in error by prior to FDA approval of version 1.0.2.2 software.
Data sourced from openFDA. This site is unofficial and independent of the FDA.