FDA Device recall Z-2255-2018
VNS Therapy Programmer, Model 3000, v1.0 System
- FDA Device
- Class II
- terminated
- Published 2018-06-27
On 2018-06-27 the FDA classified a Class II recall of VNS Therapy Programmer, Model 3000, v1.0 System by Cyberonics, citing 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 misca….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2255-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-11-13 |
| Published | 2018-06-27 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Cyberonics |
| Distribution | AL, CA, CO, DE, FL, GA, ID, IL, IN, ME, MO, MS, NC, NJ, NY, PA, TN, TX, UT, WA, WI |
Product
VNS Therapy Programmer, Model 3000, v1.0 System
Reason
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).
Identifiers
| code_info | Serial Numbers: FMT77F2, FKR57F2, FCR77F2, CJR77F2, BNT77F2, BNS77F2, 7XR77F2, 7XP57F2, 79R77F2, 90S77F2, 97Q57F2, 6NT…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, CSQ5 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2255-2018%22
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