Reported Jun 27, 2018 · Terminated
VNS Therapy Programmer, Model 3000, v1.0 System
Cyberonics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cyberonics, Inc · 100 Cyberonics Blvd · Houston, TX · 77058-2069
Is this the product you have?
VNS Therapy ProgrammerModel 3000v1.0 System
- Lot codes and dates
- Serial Numbers
250 of 250 codes
FMT77F2FKR57F2FCR77F2CJR77F2BNT77F2BNS77F27XR77F27XP57F279R77F290S77F297Q57F26NT77F29GP57F26KQ57F2B7Q57F257P57F255T77F2J6R57F2HWR77F21G7G1F21JR57F29XP57F24LR77F24GT77F24GR57F22DT77F2G2S77F2FVQ77F2G5T77F2FDQ57F2F5R57F2F2R57F2F1Q57F2GHS77F2DVR77F2DNP57F2DMYB7F2DJS77F2D1R57F2CVQ57F2H4R57F285S77F289T77F28LYB7F297YB7F26MQ57F26CQ57F25HS77F2JLQ57F2JGS77F211R57F21TQ57F21YR77F22DR77F2FXP57F2FTR77F2FPQ57F2FNQ57F2FLYB7F2FFP57F2
- Serial Numbers
- Amount recalled
- 252
Where it was sold
Why it was recalled
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).
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Cyberonics, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.