CLASS II ONGOING Device recall · Reported 12 Feb 2025 · FDA Enforcement Report
SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part recalled
LivaNova USA is recalling SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the, distributed in 41 states. The recall was initiated on 12 Dec 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1072-2025
- FDA event ID
- 95435
- Recalling firm
- LivaNova USA, Houston, TX
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Dec 2024
- FDA classified
- 31 Jan 2025
- Reported
- 12 Feb 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 12 Dec 2024 | Recall initiated by company | |
| 31 Jan 2025 | Classified by FDA | +50 days |
| 12 Feb 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanically activated component that may become stuck in a closed position, which may result in patients returning to baseline seizure frequency or depressive symptoms and in the longer term, patients may be required to undergo generator replacement surgery to replace their device.
Product as listed by the FDA
SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. Used for Vagus Nerve Stimulation (VNS).
Where it was distributed
US: AK, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, PN, SC, SD, TN, TX, VA, VT, WA, WI, WV, UT. OUS: AE, AR, AT, BE, BG, BR, CA, CL, CO, CR, CZ, DE, DK, GR, HR, IL, IN, IT, JO, KW, LB, MK, NL, OM, PA, PE, PL, QA, RO, RS, SA, SE, SG, SI, TR, TT, UK, ZA.
AlaskaArkansasArizonaCaliforniaColoradoConnecticutDelawareFloridaGeorgiaIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaineMichiganMinnesotaMissouri
Questions about this recall
Why was it recalled?
Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanically activated component that may become stuck in a closed position, which may result in patients returning to baseline seizure frequency or depressive symptoms and in the longer term, patients may be required to undergo generator replacement surgery to replace their device.
Which lots are affected?
REF/UDI-DI: 1000/05425025750405, 1000-D/05425025750528 All Serial Numbers less than 500,000
Where was it sold?
US: AK, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, PN, SC, SD, TN, TX, VA, VT, WA, WI, WV, UT. OUS: AE, AR, AT, BE, BG, BR, CA, CL, CO, CR, CZ, DE, DK, GR, HR, IL, IN, IT, JO, KW, LB, MK, NL, OM, PA, PE, PL, QA, RO, RS, SA, SE, SG, SI, TR, TT, UK, ZA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 95435| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | SenTiva, REF: 1000C, Generators Part of the VNS Therapy System recalled | LivaNova USA | Other | 41 states |
More recalls from LivaNova USA
All 47| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | SenTiva, REF: 1000C, Generators Part of the VNS Therapy System recalled | LivaNova USA | Other | 41 states |
| Device | CLASS II | VNS Therapy¿ SenTiva DUO" recalled by LivaNova USA | LivaNova USA | Packaging Defects | Nationwide |
| Device | CLASS II | Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA recalled | LivaNova USA | Device Malfunction | 7 states |
| Device | CLASS II | VNS Therapy Sentiva DUO # 1000-D recalled by LivaNova USA | LivaNova USA | Other | TX |
| Device | CLASS II | VNS Therapy¿ AspireSR¿ Generator recalled by LivaNova USA | LivaNova USA | Device Malfunction | 29 states |
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