Recall Z-0555-2018
Cyberonics, Inc · initiated December 2, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Part Number: 10-0011-0500 Serial number/UDI: 8LYB7F2/010542502575039911170920218LYB7F29910-0011-0500 D80C7F2/01054250257503991117092921D80C7F29910-0011-0500
Reason for recall
Two Model 3000 Programmers were distributed in error by prior to FDA approval of version 1.0.2.2 software.
FDA-determined cause: Employee error
Action taken
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.
Details
- Recall number
- Z-0555-2018
- Initiated
- December 2, 2017
- Terminated
- August 6, 2018
- Product code
- LYJ – Stimulator, Autonomic Nerve, Implanted For Epilepsy
- Quantity
- 2 units
- Distribution
- US Distribution to the states of : CO and ND
- Recalling firm
- Cyberonics, Inc, Houston, TX