LivaNova recalls VNS Therapy Program GMDN 3000 V1.5.2 software version devices that may display false high impedance values during patient follow-up due to a diagnostic test error.
This recall is being initiated due to reports that that the therapy programming tablet with software version 1.5 errantly performs a normal mode diagnostic test instead of the selected system diagnostic test on Model 102 and Model 102R devices, if the output current is greater than 0.5mA. This can result in false high impedance values during patient follow-up.
LivaNova is recalling VNS Therapy Program GMDN devices with software version 1.5.2 that may incorrectly perform a diagnostic test, causing false high impedance readings during patient follow-ups. This could lead to inaccurate treatment adjustments.
The device may errantly perform a normal mode diagnostic test instead of the selected system diagnostic test when output current exceeds 0.5mA. This causes false high impedance values during patient follow-up, potentially leading to inaccurate treatment adjustments.
Patients using VNS therapy devices with software version 1.5.2 (Model # 3000) are affected. The risk is low as the issue only affects diagnostic readings, not patient safety.
Check for software version 1.5.2 on your VNS Therapy Program GMDN device (Model # 3000). The recall includes specific serial numbers and UDI numbers listed in the record.
Verify your device's software version by checking the device settings or documentation. The affected version is 1.5.2.
No, this recall is for a software issue that may cause false high impedance readings during patient follow-ups, not an immediate safety risk.
Check for software version 1.5.2 on your VNS Therapy Program GMDN device (Model # 3000). The recall includes specific serial numbers and UDI numbers listed in the record.
If your device is affected, check the software version. No action is required if your device is not affected.
We’ve drafted a message you can send LivaNova to request your refund or repair — edit it as you like.
Subject: Recall Z-0663-2020 — LivaNova LivaNova Hello, I own a LivaNova that is covered by recall Z-0663-2020 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.
