Cyberonics recalls Model 3000 v1.0 VNS Therapy Programmers with specific serial numbers due to potential programming errors that could cause incorrect stimulation levels or no therapy delivery.
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).
Cyberonics is recalling VNS Therapy Programmers Model 3000 v1.0 with certain serial numbers because programming events might cause incorrect stimulation levels or no therapy delivery. This could lead to painful stimulation or lack of treatment for patients using the device.
The device may miscalculate stimulation parameters during programming events, leading to either too much stimulation (causing pain), no stimulation (stopping therapy), or insufficient stimulation (not achieving therapeutic settings). This can happen with specific models of the VNS generator.
Patients using Cyberonics VNS Therapy Programmers Model 3000 v1.0 with the listed serial numbers are affected. Those with the device who experience incorrect stimulation or no therapy delivery are most at risk.
Check if your VNS Therapy Programmer Model 3000 v1.0 has one of the listed serial numbers. The recall includes specific serial numbers starting with patterns like FMT77F2, FKR57F2, and others.
Identify if your device has a serial number from the list provided in the recall notice.
The recall affects Cyberonics VNS Therapy Programmers Model 3000 v1.0 with specific serial numbers listed in the notice.
Programming events might cause incorrect stimulation levels, leading to painful stimulation or no therapy delivery for patients using the device.
The recall notice does not specify a remedy, so no action is required beyond checking if your device is affected.
We’ve drafted a message you can send Cyberonics to request your refund or repair — edit it as you like.
Subject: Recall Z-2255-2018 — Cyberonics Cyberonics Hello, I own a Cyberonics that is covered by recall Z-2255-2018 from Cyberonics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
