CLASS II ONGOING Device recall · Reported 5 Feb 2025 · FDA Enforcement Report
VNS Therapy¿ SenTiva DUO" recalled by LivaNova USA
LivaNova USA is recalling VNS Therapy¿ SenTiva DUO", distributed nationwide in the US. The recall was initiated on 3 Jan 2025 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-1068-2025
- FDA event ID
- 96063
- Recalling firm
- LivaNova USA, Houston, TX
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Jan 2025
- FDA classified
- 30 Jan 2025
- Reported
- 5 Feb 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Medical Software
Timeline
| 3 Jan 2025 | Recall initiated by company | |
| 30 Jan 2025 | Classified by FDA | +27 days |
| 5 Feb 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Brand Name: SenTiva DUO" Product Name: VNS Therapy¿ SenTiva DUO", Model 1000-D Model/Catalog Number: 1000-D Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and external programming system used to change stimulation settings. The generator is an implantable, multi-programmable pulse generator that delivers electrical signals to the vagus nerve through the lead. The generator is housed in a hermetically sealed titanium case and is powered by a single battery. Electrical signals are transmitted from the generator to the vagus nerve by the lead. The lead and the generator make up the implantable portion of the VNS Therapy System. The VNS Therapy Programming System includes a computer pre-installed with VNS Therapy programming software and a programming wand. The physician uses the programming system to read and change generator settings. The Model 1000-D Generator was commercially approved for distribution in the U.S. on May 13, 2020 via PMA P970003/S231. Component: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS).
Where it was distributed
Worldwide - US Nationwide distribution including in the states of 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 and the countries of 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, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Iceland, Ireland, Israel, Italy, Japan, Kuwait, Lithuania, Luxembourg, New Zealand, Norway, Panama, Peru, Poland, Portugal, Qatar, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, The Netherlands, Turkey, UAE, United Kingdom.
Nationwide AlaskaArkansasArizonaCaliforniaColoradoConnecticutDelawareFloridaGeorgiaIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaineMichiganMinnesotaMissouri
Questions about this recall
Why was it recalled?
Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue.
Which lots are affected?
Lot Code: Model No 1000-D UDI-DI: 05425025750528 Lot Numbers/Serial Numbers: 324841 324842 324843 324844 324845 324846 324847 324848 324849 324850 324851 332681 332682 332684 332685 332686 332687 332688 332689 332692 332693 332695 332696 332697 332699 332700 332701 332702 332704 332705 332706 332707 332708 332709 332710 332811 332812 332813 332814 332815 332820 332823 332826 332827 332829 332830 332831 332833 339950 340073 340106 340108 340110 340111 340112 340113 340114 340115 340116 340117 340118 340119 340120 340121 340122 340569 340570 340571 340572 340573 340574 340575 340576 340578 340579 340580 340581 340583 340584 340585 340586 340587 340588 340589
Where was it sold?
Worldwide - US Nationwide distribution including in the states of 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 and the countries of 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, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Iceland, Ireland, Israel, Italy, Japan, Kuwait, Lithuania, Luxembourg, New Zealand, Norway, Panama, Peru, Poland, Portugal, Qatar, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, The Netherlands, Turkey, UAE, United Kingdom.
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.
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 | SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part recalled | LivaNova USA | Other | 41 states |
| 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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