LivaNova recalls VNS Therapy Programmer Model 3000 (v1.6) used with specific VNS generators due to false positive warnings that may cause unnecessary medical procedures. Affected users should contact LivaNova for guidance.
False positive warning may occur after: 1) VNS Generator interrogated at 0mA normal output current, 2) Generator programmed to non-0mA output current, 3) In-session re-interrogation performed. Users instructed to lower output current and widen pulse width. Only system diagnostic testing evaluates output current. Users may conclude device malfunction, could lead to medical/surgical intervention.
LivaNova is recalling its VNS Therapy Programmer Model 3000 (version 1.6) that works with certain VNS generators. False positive warnings could lead users to believe the device is malfunctioning, potentially causing unnecessary medical interventions.
The device may show false positive warnings after specific electrical conditions are met, like changing the output current or re-interrogating the generator. This could lead users to think the device is malfunctioning and seek medical intervention unnecessarily.
Patients using VNS therapy devices with the recalled programmer model are affected. Those with specific VNS generator models (103, 104, 105, 106, 8103) are most at risk.
Check for the VNS Therapy Programmer Model 3000 with version 1.6. The device is used with VNS generators models 103, 104, 105, 106, or 8103.
Reach out to LivaNova for guidance on whether your device is affected and next steps.
The device may show false positive warnings after specific electrical conditions, which could lead to unnecessary medical interventions.
The VNS Therapy Programmer Model 3000 (version 1.6) used with VNS generators models 103, 104, 105, 106, or 8103.
Check for the VNS Therapy Programmer Model 3000 with version 1.6 that works with the specified VNS generator models.
We’ve drafted a message you can send LivaNova to request your refund or repair — edit it as you like.
Subject: Recall Z-1563-2020 — LivaNova LivaNova Hello, I own a LivaNova that is covered by recall Z-1563-2020 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.
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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.
