VNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 Intended Use/Indications: Unite...
FDA Device Recall #Z-0555-2018 — Class II — December 2, 2017
Recall Summary
| Recall Number | Z-0555-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 2, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Cyberonics, Inc |
| Location | Houston, TX |
| Product Type | Devices |
| Quantity | 2 units |
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.
Distribution Pattern
US Distribution to the states of : CO and ND
Lot / Code Information
Part Number: 10-0011-0500 Serial number/UDI: 8LYB7F2/010542502575039911170920218LYB7F29910-0011-0500 D80C7F2/01054250257503991117092921D80C7F29910-0011-0500
Other Recalls from Cyberonics, Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2255-2018 | Class II | VNS Therapy Programmer, Model 3000, v1.0 System | Nov 13, 2017 |
| Z-3019-2017 | Class II | VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ ... | Jun 13, 2017 |
| Z-3020-2017 | Class II | VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ ... | Jun 13, 2017 |
| Z-0659-2016 | Class II | VNS Therapy AspireSR Generator Model 106. In... | Dec 18, 2015 |
| Z-0645-2016 | Class II | Cyberonics Vagus Nerve Stimulator VNS Therapy A... | Nov 18, 2015 |
Frequently Asked Questions
A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.