Data / Medical devices / United States / LivaNova USA, Inc.
LivaNova USA, Inc.: FDA-registered device maker in Houston, TX, United States, 1 510(k) clearance and 1 PMA approval
LivaNova USA, Inc. is registered with the FDA (registration 1644487) in Houston, TX, United States. It lists 4 device types. The FDA files 1 510(k) clearance and 1 PMA approval under its listings, the newest dated November 3, 2009. 29 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1644487
- FEI number
- 1000117004
- Address
- 100 Cyberonics BLVD., Houston, TX, United States, 77058
- Owner or operator
- LivaNova USA, Inc. (9002738)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- November 15, 2005
- Registered through
- 2026
- Brand names listed
- Model 220, Patient Magnet, VAGUS NERVE STIMULATOR (VNS) SYSTEM, VNS THERAPY MODEL 402 TUNNELER
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Instrument, Surgical, Non-Powered | HAO | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Magnet, Test, Pacemaker | DTG | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Stimulator, Autonomic Nerve, Implanted (Depression) | MUZ | 3 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Stimulator, Autonomic Nerve, Implanted For Epilepsy | LYJ | 3 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 3, 2009 | K092364 | MODEL 220 PATIENT MAGNET | DTG | Substantially Equivalent | Cyberonics, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| July 16, 1997 | P970003 | VNS THERAPY SYSTEM | LYJ | 238 | October 2, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 3, 2025 | 96063 | Class II | Ongoing | Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS), consists | Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue. | accessdata.fda.gov |
| December 12, 2024 | 95435 | Class II | Ongoing | SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. Used for Vagus Nerve Stimulation (VNS). | 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 thei | accessdata.fda.gov |
| December 2, 2021 | 89335 | Class II | Terminated | Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Model 303-20 PereniaDURA Lead (2.0 mm electrode inner diameter) and Model 303-30 PereniaDURA Lead (3.0 mm electrode inner diameter) | A manufacturing issue may cause the silicone tubing wall thickness of vagus nerve stimulation leads to be less than the design specification. If the tubing becomes completely breached, the patient may experience discomfort or pain due to delivery of stimulation to an unintended location. If the inner lead conductor is exposed to body fluids the lead may brea | accessdata.fda.gov |
| November 12, 2020 | 86776 | Class II | Terminated | VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of chronic or recurrent depression in patients who are experiencing a treatment-resistant or treatment- intolerant depressive episode. | During internal testing, it was found that upon a device reset, the Generator exhibits the incorrect Model Number when interrogated. | accessdata.fda.gov |
| September 28, 2020 | 86570 | Class II | Terminated | VNS Therapy AspireSR Generator | 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. | accessdata.fda.gov |
| February 4, 2020 | 84723 | Class II | Ongoing | VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS Therapy generators. | False positive warning may occur after: 1) VNS Generator interrogated at 0mA normal output current, 2) Generator programmed to non-0mA output current, 3) In-session re-interrogation performed. Users instructed to lower output current and widen pulse width. Only system diagnostic testing evaluates output current. Users may conclude device malfunction, could l | accessdata.fda.gov |
| August 22, 2019 | 83873 | Class I | Terminated | VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy | Sentiva generators may reset and become disabled within 60 days of enabling. Physicians can re-enable but devices will continue to be susceptible to resets. If a device experiences this issue, this may lead to additional surgery (premature replacement of generator), or patients may return to baseline seizure frequency or depressive symptoms due to cessation | accessdata.fda.gov |
| August 13, 2019 | 84710 | Class II | Terminated | VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800 Model 1000 Generator Sample Labels 26-0009-9600 Patient s Manual for Depression 26-0009-9500 Patient s Manual for Epilepsy 76-0000-5000 VNS Therapy System | Firm identified a subset of its generators that were sterilized one additional sterilization cycle, which does not meet the firm's quality specifications. | accessdata.fda.gov |
| November 16, 2018 | 84170 | Class II | Ongoing | VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly | This recall is being initiated due to reports that that the therapy programming tablet with software version 1.5 errantly performs a normal mode diagnostic test instead of the selected system diagnostic test on Model 102 and Model 102R devices, if the output current is greater than 0.5mA. This can result in false high impedance values during patient follow-u | accessdata.fda.gov |
| November 16, 2018 | 84029 | Class II | Terminated | Cyberonics VNS Therapy AspireHC Model 105 Generator, 26-0007-4000/3. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator. | This recall is an expansion of Z-3019-2017 and Z-3020-2017, which was initiated to fix the devices premature battery depletion, caused by electrical leakage on the circuit board assemblies of the Models 105 and 106 generators. *Note this recall occurred in November 2018. | accessdata.fda.gov |
| November 16, 2018 | 82566 | Class II | Ongoing | 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 im | Lead impedance values reported by the affected VNS generator will be higher compared to those reported by previous models. This is due to a change in the timing of when affected VNS generator takes the lead impedance measurement during diagnostic testing. As a result, normal impedance ranges for the affected VNS generator have shifted relative to the existin | accessdata.fda.gov |
| January 24, 2018 | 80424 | Class II | Terminated | VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2 | Unintended warning message displayed on generators programmed with a Model 3000 v.1.0.2.2 programmer. | accessdata.fda.gov |
| December 2, 2017 | 78914 | Class II | Terminated | VNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 Intended Use/Indications: United States Indications for Use: Epilepsy : The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the fre | Two Model 3000 Programmers were distributed in error by prior to FDA approval of version 1.0.2.2 software. | accessdata.fda.gov |
| November 13, 2017 | 80062 | Class II | Terminated | VNS Therapy Programmer, Model 3000, v1.0 System | Certain Model 3000 programming events can result in miscalculation of parameters stored in the Models 103, 104, 105, and 106 generators. During these programming events, the miscalculations can lead to: " Delivery of more stimulation than intended, resulting in painful stimulation or other common side effects (Model 106 only); " No stimulation in the case of | accessdata.fda.gov |
| June 13, 2017 | 77698 | Class II | Terminated | VNS Therapy AspireHC Generator, VNS Therapy AspireSR Generator. Model No. 105. Product Usage: United States Indications for Use: Epilepsy (PMA 970003): The VNS Therapy System is indicated for use as an adjunctive therapy | Manufacturing process used to assemble the circuit board may result in some devices experiencing a faster than expected reduction in device longevity. | accessdata.fda.gov |
| December 18, 2015 | 72896 | Class II | Terminated | VNS Therapy AspireSR Generator Model 106. Indicated for use as an adjunctive therapy in reducing the frequency of seizures. | Recall being initiated in response to three reports of "Burst Watchdog Timeout" events occurring with the Model 106 AspireSR Generator, resulting in a device reset condition where stimulation output is disabled. | accessdata.fda.gov |
| November 18, 2015 | 72698 | Class II | Terminated | Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106 | Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat Detection' feature and exhibit the potential for decreased battery longevity. | accessdata.fda.gov |
| October 7, 2015 | 72385 | Class II | Terminated | Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106 | Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat Detection' feature and exhibit potential for decreased battery longevity. | accessdata.fda.gov |
| March 6, 2015 | 70804 | Class II | Terminated | VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104; CYBERONICS, INC. | The pulse generators have a lower battery longevity than specified in their design requirement as a result of the devices being inadvertently left in a programmed ON state during manufacture. | accessdata.fda.gov |
| November 20, 2014 | 69844 | Class II | Terminated | Cyberonics VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Therapy System consists of the implantable VNS Therapy Generator, the VNS Therapy Lead, and the external programming system used to change the stim | The recalled product was distributed with an incorrect serial number printed on the device's label. | accessdata.fda.gov |
| August 12, 2011 | 59818 | Not yet classified | Terminated | VNS Therapy Aspire HC Generator and VNS, Model 105 Cyberonics, Inc. 100 Cyberonics Blvd., Houston, TX 77058 For implantation in humans to treat Epilepsy and Depression. | The devices are being recalled because the output current delivered to the vagus nerve is less than the design intent and there is a potential charge imbalance at the lead cathode and generator-can during stimulation. | accessdata.fda.gov |
| May 6, 2011 | 59139 | Not yet classified | Terminated | VNS Therapy Demipulse Model 103 Generator Cyberonics, Inc. Houston, Texas, Model 103 Generators are provided in a sterile single use packages as part of the VNS Therapy System. Product labeling may be found at http://us. | An investigation was initiated based on a report from the field in which an Intensive Follow-up Indicator (IFI) message was unexpectedly received by a medical professional when using Model 250 version 8.0 software to interrogate a patient's Model 103 Generator. | accessdata.fda.gov |
| April 6, 2010 | 55446 | Not yet classified | Terminated | VNS Therapy Demipulse Generator, Model 103 and VNS Therapy Demipulse Duo Generator, Model 104 VNS Therapy Programming System, Model 250 Version 7.0 and 7.1 Software | Battery life projection is inaccurate. | accessdata.fda.gov |
| November 20, 2009 | 54020 | Not yet classified | Terminated | VNS Therapy Demipulse Generator, Model 103 and VNS Therapy Demipulse Duo Generator, Model 104. The Cyberonics VNS Therapy system consists of an implantable VNS Therapy Generator, the VNS Therapy Lead, and the external pr | Under certain conditions, product's battery life can be reduced. | accessdata.fda.gov |
| July 24, 2009 | 53131 | Not yet classified | Terminated | Cyberonics VNS Therapy Programming M250 Programming System, model number 250, version 4.6, 6.1, 7.0 and 7.1. The Model 250 Handheld software is provided on flashcards packaged in software envelopes or pre-installed on ha | Some VNS Therapy System replacement Demipulse generators reporting low lead impedance readings. In rare instances, a system diagnostic test using Model 250 Programming Software (versions 7.1 and earlier) may report "Lead Impedance: OK" when a short-circuit condition exists. | accessdata.fda.gov |
| February 7, 2008 | 47442 | Not yet classified | Terminated | Cyberonics VNS Therapy Demipulse Generator, Model 103; an implantable, multiprogrammable, vagus nerve stimulator. | Reset/disabling of the VNS Therapy Demipulse Generator and Demipulse Duo Generator due to magnet interference resulting in the loss of stimulation. | accessdata.fda.gov |
| October 25, 2007 | 45958 | Not yet classified | Terminated | Cyberonics, VNS Therapy System Model 250 Handheld programming system using Dell x5 handheld and preprogrammed with software v7.1 and higher; manufactured by Cyberonics, Inc., Houston, TX. | Screen Freezes-- The Dell X5 Handheld PC screen will freeze caused due to incompatibility between the Microsoft 2002 OS and the model Dell X5 handheld computer. Once frozen, the handheld device becomes non-responsive to user input. | accessdata.fda.gov |
| August 2, 2007 | 37912 | Not yet classified | Terminated | Cyberonics Neuro Cyberonics Prosthesis System NCP Bipolar Lead, Model #300; Sterile, Single use only; Distributed by Cyberonics, Inc., Houston, TX 77058. | Dissolution/Fractures to the leads of the VNS Therapy System | accessdata.fda.gov |
| October 17, 2006 | 36672 | Not yet classified | Terminated | Cyberonics VNS Therapy System, Model 250-''HAND HELD'' programming software v6.1, v6.1.7, v7.0 and v7.1.3; manufactured by Cyberonics, Inc., Houston, TX. | During programming, pulse generator may be inadvertently set to 8.0 mA output, regardless of the mA range selected by the clinician | accessdata.fda.gov |
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Updated October 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.