VNS Therapy® SenTiva™ Model 1000 GeneratorRecalls & reported problems

Summary

The FDA's MAUDE database contains 3,378 adverse event reports that list this exact device (DI 05425025750405), received between Dec 22, 2017 and Sep 30, 2026 — classified as 188 deaths, 1,900 injuries, 1,290 malfunctions.

The most frequently reported specific device problem is “High impedance” (272 reports).

3 FDA recall records name this device's identifier, 3 still open.

28 other recalls cover devices cleared under the same FDA submission (P970003); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jan 3, 2025Class IIOpen, Classified

   Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue.

   Z-1067-2025 · Root cause: Device Design · Recall details · FDA record ↗

2. Dec 12, 2024Class IIOpen, Classified

   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.

   Z-1073-2025 · Root cause: Device Design · Recall details · FDA record ↗

3. Dec 12, 2024Class IIOpen, Classified

   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.

   Z-1072-2025 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 3,378 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Implant Pain; Local Reaction

  MAUDE report 50951560 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Convulsion, Clonic; Syncope/Fainting

  MAUDE report 50937159 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a newly implanted device was programmed to a higher output current than intended during the implant procedure due to a programming error. The output current was set to 2.5 mA instead of the intended 0.25 mA. At a follow-up visit, the output current was corrected to 0.25 mA. The patient's mother later stated that for 2-3 weeks, the patient could not eat or sleep, his eyes were kind of like a bomb had exploded.No other relevant information has been received to date.

  Patient problems: Decreased Appetite; Sleep Dysfunction; Visual Disturbances

  MAUDE report 50933153 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was seen with an infection shortly after generator placement. The patient was prescribed antibiotics and was improving. Device history records were reviewed and passed all functional specifications and quality tests and were sterilized prior to distribution.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Medical device site infection

  MAUDE report 50916461 ↗
• MalfunctionSep 25, 2026Inappropriate or Unexpected Reset

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50906178 ↗
• MalfunctionSep 25, 2026Failure to Sense

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50905977 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Convulsion, Clonic

  MAUDE report 50903509 ↗
• MalfunctionSep 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient experienced a seizure the following day after every VNS stimulation increase. It was reported the patient experienced 2 seizures a year prior to VNS. No other relevant information has been received to date.

  Patient problems: Convulsion, Clonic

  MAUDE report 50903240 ↗
• DeathSep 25, 2026Adverse Event Without Identified Device or Use Problem

  LivaNova was informed that the patient had passed away, no further information was received.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903236 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was brought into surgery due to a stitch abscess and to clean out the area. The initial incision site healed but a small abscess developed around a suture. Update was received that patient underwent wound revision/clean out. The surgeon assessed that the event was due to a reaction to antibiotics and sutures used.Device history records were reviewed for generator and lead. The generator and lead passed all specifications prior to distribution and were HP sterilized.No other relevant information has been received to date.

  Patient problems: Medical device site infection

  MAUDE report 50888726 ↗
• MalfunctionSep 24, 2026Premature Discharge of Battery

  It was reported from patient's mother that at the last visit the battery was seen OK and now at the most recent visit the battery level was low. It was suspected that the battery depleted prematurely.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883690 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Skin Infection

  MAUDE report 50873617 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  The patient had their generator explanted due to an infection and they are now being referred to undergo reimplant indicating that the infection has since resolved.Device evaluation is not necessary because the reported event has been determined as not related to the functionality or delivery of therapy of the device.The device history records for the generator were reviewed. The generator was confirmed to have been HP sterilized prior to distribution into the field. The device passed all specifications, including Quality Control inspection, and showed no non-conformities, prior to its release into the field for distribution.No other relevant information has been received to date.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Medical device site infection

  MAUDE report 50869142 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  A few days after undergoing a generator replacement the patient started experiencing nausea and upset stomach. It was further explained that the patient had difficulty keeping food and water down, nausea and vomiting and they were instructed to tape their magnet over the generator but the nausea and vomiting continued. The patient was seen at the hospital where their device was disabled but the nausea, discomfort and stomach issues persisted so the VNS device was ruled out as a cause. But given the closeness to the patient feeling ill and them undergoing a generator replacement, it is still unclear is the events are related to the replacement surgery.The device history records for the generator were reviewed. The generator was confirmed to have been HP sterilized prior to distribution into the field. The device passed all specifications, including Quality Control inspection, and showed no non-conformities, prior to its release into the field for distribution.No other relevant information has been received to date.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Nausea; Unspecified Gastrointestinal Problem; Vomiting

  MAUDE report 50868840 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient has lost weight and reported experiencing discomfort at their generator site. The patient's device was interrogated and noted to be functioning within normal limits. The patient has been referred for a repositioning surgery.No known surgical intervention has occurred to date.No other relevant information has been received to date.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Implant Pain

  MAUDE report 50868614 ↗
• MalfunctionSep 23, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Convulsion, Clonic

  MAUDE report 50867648 ↗
• DeathSep 23, 2026Adverse Event Without Identified Device or Use Problem

  The patient recently passed away, and the medical examiner would like to have the device interrogated. The patient's device was explanted but has not been received by product analysis to date.No other relevant information has been received to date.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50867047 ↗
• DeathSep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented with a new onset of "choreiform-type movement disorder" two days after a VNS battery replacement. Brain MRI and CSF were reportedly unremarkable. Normal and Autostim output currents were turned off. Update was later received that the event was more aligned with the movement disorder, ballismus. The VNS was disabled for several hours to assess whether the stimulation was contributing to the patient's symptoms. Despite cessation of stimulation, no improvement or reduction in the choreiform/ballistic movements was observedUpdate was later received that the patient passed away. The patient died due to worsening hypoxaemic respiratory failure from aspiration pneumonia. It was noted by the treating team that the medications administered in an attempt to control the severe movement disorder may have increased the patient's respiratory vulnerability. Additionally, while the patient had a known history of KBG Syndrome, the underlying condition was not considered sufficient to explain the abrupt onset and severity of the neurological symptoms. As such, clinicians indicated that the movement disorder itself, and/or complications associated with its t

  Patient problems: Movement Disorder

  MAUDE report 50860474 ↗
• MalfunctionSep 22, 2026Output below Specifications

  It was reported that when the device was checked diagnostics showed a LOW output current. Tablet data was provided for review. No other relevant information has been received to date.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50858600 ↗
• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Medical device site infection

  MAUDE report 50848198 ↗
• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was seen with an infection. Device history records were reviewed for the generator and lead. The generator and lead passed all specifications prior to distribution. The generator and lead were HP sterilized.No other relevant information has been received to date.

  Patient problems: Post Operative Wound Infection

  MAUDE report 50843169 ↗
• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient complained of redness and irritation at the site of the VNS incision. Due to the patient complaint today, the treating neurologist turned the VNS off until after follow up.No other relevant information has been received to date.

  Patient problems: Anaphylactoid / Anaphylaxis

  MAUDE report 50840184 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Bradycardia; Vomiting

  MAUDE report 50829733 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Medical device site infection

  MAUDE report 50829211 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Local Reaction

  MAUDE report 50828651 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P970003. One submission often covers many models, so check the product and lot details in each record.

• Z-1068-2025 · Jan 3, 2025 · Open, Classified
  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" Syste
• Z-0532-2022 · Dec 2, 2021 · 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 e
• Z-0462-2021 · Sep 28, 2020 · Terminated
  VNS Therapy AspireSR Generator
• Z-1563-2020 · Feb 4, 2020 · Open, Classified
  VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS Therapy generators.
• Z-0561-2020 · Aug 22, 2019 · Terminated
  VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy
• Z-1118-2020 · Aug 13, 2019 · 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
• Z-0663-2020 · Nov 16, 2018 · Open, Classified
  VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly
• Z-0869-2020 · Nov 16, 2018 · Terminated
  Cyberonics VNS Therapy AspireSR, Model 106 Generator, 26-0007-8400/1. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator.
• Z-0346-2020 · Nov 16, 2018 · Open, Classified
  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 stim
• Z-0868-2020 · Nov 16, 2018 · 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.
• Z-2572-2018 · Jan 24, 2018 · Terminated
  VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2
• Z-0555-2018 · Dec 2, 2017 · 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 a
• Z-2255-2018 · Nov 13, 2017 · Terminated
  VNS Therapy Programmer, Model 3000, v1.0 System
• Z-0659-2016 · Dec 18, 2015 · Terminated
  VNS Therapy AspireSR Generator Model 106. Indicated for use as an adjunctive therapy in reducing the frequency of seizures.
• Z-0645-2016 · Nov 18, 2015 · Terminated
  Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106

…and 13 more.