LivaNova recalls certain VNS Therapy AspireSR Generator devices with serial numbers containing an extra digit that may not work with software version 11.0.4. Affected units can be identified by specific serial numbers listed in the recall notice.
Due to an extra digit being inadvertently added to the serial number of a subset of implantable pulse generators, they become not compatible with therapy programmers with software version 11.0.4.
LivaNova is recalling certain VNS Therapy AspireSR Generator devices that have an extra digit in their serial number. This makes them incompatible with therapy programmers using software version 11.0.4. If you own one of these devices, you should contact LivaNova for guidance.
The extra digit in the serial number causes the device to be incompatible with therapy programmers running software version 11.0.4. This means the device may not function properly with the intended software, but it does not pose a safety risk.
People who own or use the VNS Therapy AspireSR Generator with the specific serial numbers listed in the recall notice. The risk is low because the issue only affects compatibility with certain software versions, not safety.
Check if your VNS Therapy AspireSR Generator has a serial number that appears in the list provided by LivaNova. The affected units have serial numbers with an extra digit that makes them incompatible with software version 11.0.4.
Compare your device's serial number to the list of affected serial numbers provided in the recall notice.
Reach out to LivaNova for instructions on how to proceed if your device is affected.
The recall is due to an extra digit being inadvertently added to the serial number of a subset of implantable pulse generators, which causes them to be incompatible with therapy programmers using software version 11.0.4.
No, the device does not pose a safety risk. The issue is only about compatibility with specific software versions, so you can continue using it if your therapy programmer is on an older software version.
Check your device's serial number against the list of affected serial numbers provided in the recall notice. Affected units have serial numbers with an extra digit that makes them incompatible with software version 11.0.4.
We’ve drafted a message you can send LivaNova to request your refund or repair — edit it as you like.
Subject: Recall Z-0462-2021 — LivaNova LivaNova Hello, I own a LivaNova that is covered by recall Z-0462-2021 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.
