LivaNova SENTIVA DUO Device Shows Wrong Model Number After Reset
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.
Lower-risk recall
During internal testing, it was found that upon a device reset, the Generator exhibits the incorrect Model Number when interrogated.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/63927-livanova-sentiva-duo-device-shows-wrong-model-number-after-reset.
Source Summary by GovInfoNow · govinfonow.com/recall/63927-livanova-sentiva-duo-device-shows-wrong-model-number-after-reset · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0535-2021
Cite this page
“LivaNova SENTIVA DUO Device Shows Wrong Model Number After Reset.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63927-livanova-sentiva-duo-device-shows-wrong-model-number-after-reset. Based on FDA recall #Z-0535-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0535-2021%22&limit=1).
Why it’s dangerous
The device displays an incorrect model number when reset during internal testing. This could lead to misidentification but does not cause injury or malfunction.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
LivaNova- Category
Medical device
What to do — step by step
Check Device Serial Number
Look for the serial numbers listed: 311298, 310443, 310068, 310353, 310531, 310351, 310380, 310348.
How this recall unfolded
Recall timeline
FDA terminated this recall 2.2 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
What should I do if I have this device?
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.
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Where this comes from
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.
- Official source: FDA Recall #Z-0535-2021 (November 12, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0535-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.