LivaNova recalls SENTIVA DUO device model 1000-D with serial numbers 311298, 310443, 310068, 310353, 310531, 310351, 310380, 310348 due to incorrect model number display after reset.
During internal testing, it was found that upon a device reset, the Generator exhibits the incorrect Model Number when interrogated.
LivaNova is recalling SENTIVA DUO devices with specific serial numbers because they show the wrong model number after a reset. This issue does not affect safety or function but may cause confusion in device identification.
The device displays an incorrect model number when reset during internal testing. This could lead to misidentification but does not cause injury or malfunction.
Patients using the SENTIVA DUO device for treatment-resistant depression are affected. Those with the listed serial numbers are most at risk of confusion during device identification.
Check for serial numbers 311298, 310443, 310068, 310353, 310531, 310351, 310380, or 310348 on the device. The device is labeled for treating chronic or recurrent depression.
Look for the serial numbers listed: 311298, 310443, 310068, 310353, 310531, 310351, 310380, 310348.
The device shows the wrong model number after a reset during internal testing, which could cause confusion in identification but does not affect safety or function.
No, this issue does not cause injury or malfunction. It only affects device identification.
Check your device's serial number against the list provided. If it matches, you may keep using it but be aware of potential identification confusion.
We’ve drafted a message you can send LivaNova to request your refund or repair — edit it as you like.
Subject: Recall Z-0535-2021 — LivaNova LivaNova Hello, I own a LivaNova that is covered by recall Z-0535-2021 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.
