VNS Therapy Programmer, Model 3000, v1.0 System
FDA Device Recall #Z-2255-2018 — Class II — November 13, 2017
Recall Summary
| Recall Number | Z-2255-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 13, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Cyberonics, Inc |
| Location | Houston, TX |
| Product Type | Devices |
| Quantity | 252 |
Product Description
VNS Therapy Programmer, Model 3000, v1.0 System
Reason for Recall
Certain Model 3000 programming events can result in miscalculation of parameters stored in the Models 103, 104, 105, and 106 generators. During these programming events, the miscalculations can lead to: " Delivery of more stimulation than intended, resulting in painful stimulation or other common side effects (Model 106 only); " No stimulation in the case of device disablement (Burst Watchdog Timeout), resulting in no therapy to the patient (Model 106 only); " Delivery of less stimulation than intended, resulting in therapeutic settings not being achieved within device specification (Models 103, 104, 105, or 106); and/or " Delays or absence of the 75% and 50% battery life indicators displayed by the programming software (Models 103, 104, 105, or 106).
Distribution Pattern
AL, CA, CO, DE, FL, GA, ID, IL, IN, ME, MO, MS, NC, NJ, NY, PA, TN, TN, TX, UT, WA and WI
Lot / Code Information
Serial Numbers: FMT77F2, FKR57F2, FCR77F2, CJR77F2, BNT77F2, BNS77F2, 7XR77F2, 7XP57F2, 79R77F2, 90S77F2, 97Q57F2, 6NT77F2, 9GP57F2, 6KQ57F2, B7Q57F2, 57P57F2, 55T77F2, J6R57F2, HWR77F2, 1G7G1F2, 1JR57F2, 9XP57F2, 4LR77F2, 4GT77F2, 4GR57F2, 2DT77F2, G2S77F2, FVQ77F2, G5T77F2, FDQ57F2, F5R57F2, F2R57F2, F1Q57F2, GHS77F2, DVR77F2, DNP57F2, DMYB7F2, DJS77F2, D1R57F2, CVQ57F2, H4R57F2, 85S77F2, 89T77F2, 8LYB7F2, 97YB7F2, 6MQ57F2, 6CQ57F2, 5HS77F2, JLQ57F2, JGS77F2, 11R57F2, 1TQ57F2, 1YR77F2, 2DR77F2, ,FXP57F2 , FTR77F2, FPQ57F2, FNQ57F2, FLYB7F2, FFP57F2, GGT77F2, GSQ57F2, CMS77F2, H1R77F2, H3R57F2, 7LS77F2, 9KR57F2, 9NS77F2, 65R57F2, B8R77F2, B9T77F2, 5D0C7F2, B9YB7F2, BJR57F2, JCQ57F2, J9YB7F2, HMYB7F2, CDQ57F2, FXQ57F2, G5S77F2, G3R77F2, FRQ57F2, G7YB7F2, FLS77F2, G90C7F2, FGR77F2, FFT77F2, G9Q57F2, FCT77F2, G9R57F2, F9YB7F2, F9S77F2, F8T77F2, GDQ57F2, F7R57F2, F4T77F2, DWR77F2, DTR77F2, DSQ57F2, GMQ57F2, DLS77F2, DH0C7F2, DGS77F2, DGP57F2, GZR77F2, D1Q57F2, CSQ57F2, CLS77F2, C9YB7F2, C70C7F2, H1R57F2, C1R77F2, 7MS77F2, 78YB7F2, 9SQ57F2, 5VQ57F2, 5RQ57F2, B60C7F2, 5NQ57F2, 5MR77F2, 5KS77F2, B8T77F2, BHP57F2, BJR77F2, 4JS77F2, H4T77F2, JZQ57F2, JMS77F2, JMQ57F2, JG0C7F2, JBQ57F2, J8T77F2, ,HZQ57F2, J7R57F2, HVR77F2, HTP57F2, HNS77F2, HMQ57F2, HKQ57F2, H7S77F2, D3R57F2, 1CQ57F2, 1HT77F2, 1MYB7F2, 2CP57F2, 2LYB7F2, CLYB7F2, CMYB7F2, B4R77F2, B2S77F2, B0R57F2, 9QS77F2, D8Q57F2, 960C7F2, 95T77F2, 8JR77F2, 8HR57F2, BXP57F2, BWR77F2, BTQ77F2, C8YB7F2, C60C7F2, BLR77F2, BLQ57F2, BGR77F2, BGP57F2, CHQ57F2, CKR57F2, CPP57F2, CSR77F2, CTQ77F2, CXR77F2, 9MS77F2, 9JR77F2, 9DQ57F2, D7S77F2, 94T77F2, 8PQ57F2, BWQ77F2, BSR77F2, BNQ57F2, C9R57F2, C8R57F2, C5R57F2, CF0C7F2, C3R57F2, CFP57F2, BDT77F2, B9S77F2, B5R57F2, CPQ57F2, B4R57F2, D2R57F2, 9KQ57F2, D5R77F2, 9F0C7F2, 980C7F2, D9YB7F2, 8WR77F2, DB0C7F2, 9P7G1F2, D3S77F2, D6R57F2, D7R57F2, 9CR77F2, 9G0C7F2, 96R57F2, DFP57F2, C0S77F2, BN7G1F2, BQ7G1F2, C8S77F2, CB0C7F2, CCR77F2, BHR57F2, CHP57F2, BCR77F2, BBR77F2, BB0C7F2, B90C7F2, B70C7F2, B2R57F2, 9VP57F2, 9TQ57F2, 9GR57F2, 9FP57F2, 9BS77F2, ,98R57F2 ,D80C7F2, 970C7F2, D8YB7F2, 95R77F2, 8YR77F2, C1R57F2, C80C7F2, C3R77F2, CNS77F2, 9VQ77F2, D4T77F2, 9DR77F2, 91R57F2, 8VQ77F2, 8RQ57F2, DBS77F2, 8JS77F2, C0R57F2, BTR77F2, BMYB7F2, BKR77F2, BBP57F2 and B8S77F2
Other Recalls from Cyberonics, Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0555-2018 | Class II | VNS(R) Therapy Programmer, GMDN: 44077, Model ... | Dec 2, 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.