LivaNova recalls VNS Therapy Programming System Model 3000 v1.0.2.2 due to unintended warning messages displayed on generators. Affected units have specific serial numbers and part numbers. No remedy is stated in the recall notice.
Unintended warning message displayed on generators programmed with a Model 3000 v.1.0.2.2 programmer.
LivaNova is recalling VNS Therapy Programming System Model 3000 version 1.0.2.2 because it displays unintended warning messages. This recall affects specific units with unique serial numbers and part numbers. The issue does not pose a direct safety risk but requires attention to prevent potential confusion in medical device programming.
The VNS Therapy Programming System Model 3000 v1.0.2.2 displays unintended warning messages on the device's generators. This could lead to confusion during programming sessions but does not cause physical injury or damage to the patient.
Medical professionals who use this VNS therapy programming system for patients with vagus nerve stimulation implants. The risk is low as the issue involves unintended warning messages rather than physical harm.
Check for the model number '3000' and version 'v1.0.2.2' on the device. Affected units have specific serial numbers and part numbers listed in the recall notice, including the UDI numbers starting with FMT77F2, FKR57F2, FCR77F2, etc.
Verify the device version by checking the model number and version on the VNS Therapy Programming System. If it matches Model 3000 v1.0.2.2, it is affected.
No, the recall involves unintended warning messages that do not pose a direct safety risk. The issue is related to potential confusion during programming but does not cause injury.
Check the device for the model number '3000' and version 'v1.0.2.2'. Affected units have specific serial numbers and part numbers listed in the recall notice, including UDI numbers starting with FMT77F2, FKR57F2, etc.
The recall notice does not specify a remedy. You should check the device version and contact LivaNova for further guidance if needed.
We’ve drafted a message you can send LivaNova to request your refund or repair — edit it as you like.
Subject: Recall Z-2572-2018 — LivaNova LivaNova Hello, I own a LivaNova that is covered by recall Z-2572-2018 from LivaNova. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
