LivaNova SenTiva VNS Therapy Generators Recalled for Potential Device Reset
LivaNova is recalling SenTiva VNS Therapy generators that may reset and become disabled within 60 days of enabling, potentially requiring additional surgery or causing a return of symptoms.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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…"
Plain-English summary
LivaNova USA Inc is recalling 1,687 SenTiva VNS Therapy generators, Model # 1000, for vagal nerve stimulation therapy. The recall affects implanted devices with serial numbers greater than or equal to 100000 that did not undergo the internal error screen. These devices were distributed across 40 U.S. states and the District of Columbia, as well as 12 foreign countries.
The recall is due to a defect where the generators may reset and become disabled within 60 days of being enabled. While physicians can re-enable the devices, they remain susceptible to further resets. If a device experiences this issue, it may lead to additional surgery for premature replacement of the generator, or patients may return to baseline seizure frequency or depressive symptoms due to the cessation of intended stimulation.
Patients with these implanted devices should contact their physician for evaluation and management of the device status.
The recalled product
- Product
- VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy
- Manufacturer
- LivaNova USA Inc
- Affected units
- 1,687
Distribution
Related recalls
Same manufacturer · LivaNova USA Inc
See all →- HighVNS Therapy Generators May Stop Delivering Stimulation Due to Component Failure
FDA (Devices) · 2025-02-12
- HighVNS Therapy Generator May Stop Delivering Stimulation Due to Mechanical Defect
FDA (Devices) · 2025-02-12
- HighImplantable VNS Therapy Generators May Stop Delivering Treatment
FDA (Devices) · 2025-02-05
- HighImplantable Vagus Nerve Stimulation Device May Stop Delivering Therapy
FDA (Devices) · 2025-02-05
- HighVagus Nerve Stimulation Therapy Leads Recalled for Tubing Wall Defect
FDA (Devices) · 2022-02-09
Same hazard · device malfunction
See all →- SevereMedtronic MiniMed Flex Insulin Pumps Recalled for Failed Verification Tests
FDA (Devices) · 2026-10-14
- ModerateWilson-Cook Recalls Hemospray Endoscopic Hemostat Due to Adherence Issues
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Et Control Software Recalled for Anesthetic Delivery Interruption
FDA (Devices) · 2026-09-23
Similar recalls
- HighImplantable VNS Therapy Generators May Stop Delivering Treatment
FDA (Devices) · 2025-02-05
- HighVNS Therapy Generator May Stop Delivering Stimulation Due to Mechanical Defect
FDA (Devices) · 2025-02-12
- HighImplantable Vagus Nerve Stimulation Device May Stop Delivering Therapy
FDA (Devices) · 2025-02-05
- ModerateLivaNova Recalls Six VNS Therapy SENTIVA Generators for Sterilization Error
FDA (Devices) · 2020-02-19
- HighVNS Therapy Generators May Stop Delivering Stimulation Due to Component Failure
FDA (Devices) · 2025-02-12
- ModerateLivaNova VNS Therapy System Recall Due to Impedance Measurement Shift
FDA (Devices) · 2019-11-13