Cyberonics recalls Model 3000 VNS Therapy Programmers with v1.0.2.2 software that were distributed before FDA approval. These devices may have been used without proper software validation.
Two Model 3000 Programmers were distributed in error by prior to FDA approval of version 1.0.2.2 software.
Cyberonics is recalling VNS Therapy Programmers with Model 3000 v1.0.2.2 software that were distributed before FDA approval. This could mean the software wasn't properly validated for safety before being used in medical treatments.
The software version was distributed before FDA approval, meaning it wasn't validated for safety. This could lead to improper device function if the software isn't updated to the approved version.
Patients using VNS Therapy for epilepsy or depression who own Model 3001 VNS Programmers with v1.0.2.2 software are affected. Medical professionals using these devices for treatment are at higher risk.
Check for the Model 3000 VNS Therapy Programmer with v1.0.2.2 software. The serial number starts with 8LYB7F2 or D80C7F2.
Verify the software version on your device; if it shows v1.0.2.2, it is part of the recall.
The recall is for software distributed before FDA approval, but it does not indicate an immediate safety risk. The device may need software updates to be safe.
Check the software version on your device; if it shows v1.0.2.2, it is part of the recall. The serial number starts with 8LYB7F2 or D80C7F2.
Check the software version to see if it is v1.0.2.2. If so, contact Cyberonics for guidance on updating the software.
We’ve drafted a message you can send Cyberonics to request your refund or repair — edit it as you like.
Subject: Recall Z-0555-2018 — Cyberonics Cyberonics Hello, I own a Cyberonics that is covered by recall Z-0555-2018 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.
