VNS Therapy® AspireSR® Model 106 GeneratorRecalls & reported problems

Summary

The FDA's MAUDE database contains 2,934 adverse event reports that list this exact device (DI 05425025750061), received between May 22, 2017 and Sep 30, 2026 — classified as 151 deaths, 1,673 injuries, 1,110 malfunctions.

The most frequently reported specific device problem is “Premature End-of-Life Indicator” (343 reports).

1 FDA recall record name this device's identifier.

29 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. Dec 18, 2015Class IITerminated

   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.

   Z-0659-2016 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 2,934 reports, in the reporter's own words as published by the FDA.

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

  Patient problems: Discomfort; Voice alteration

  MAUDE report 50952238 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Vertigo; Visual Disturbances

  MAUDE report 50940892 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Convulsion, Clonic; Stroke/CVA

  MAUDE report 50924351 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Bradycardia; Fatigue

  MAUDE report 50886614 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient's generator was removed due to an infection. Device history records for the patient's generator were reviewed. The device passed all functional specifications and quality tests and were sterilized prior to distribution. Device evaluation is not necessary as the reported event is not related to the functionality or delivery of therapy of the device.No other relevant information is available to date.

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

  MAUDE report 50884610 ↗
• MalfunctionSep 23, 2026High impedance

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

  MAUDE report 50873390 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  It was reported that the patient has not been seen by a VNS provider in multiple years. The patient is experiencing an increase in seizures. The patient has had several hospital visits but was sent back to their nursing facility after each trip.Additional information later received noting that the patient underwent a prophylactic generator replacement. No other relevant information has been received to date.

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

  MAUDE report 50867934 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  Implant card received noting that the patient underwent a generator replacement due to stimulation not being consistent. The explanted generator 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

  MAUDE report 50867388 ↗
• InjurySep 22, 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 50858895 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Implant Pain

  MAUDE report 50830377 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported by a patient's mother that that after the patient's VNS stimulation was activated the patient experienced a drop in oxygen saturation down to 88-90%. The patient's mother reported that the patient needed supplemental oxygen due to the drop in oxygen saturation. It was reported that the patient has a history of sleep apnea and that the patient's physician thinks VNS stimulation may be contributing to worsening of the patient's underlying apnea. No other relevant information is available to date.

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

  MAUDE report 50820702 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  The patient missed one of their scheduled office visit due to experiencing seizures and has since been referred for a battery replacement.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; Convulsion, Clonic

  MAUDE report 50790558 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

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

  MAUDE report 50764434 ↗
• DeathSep 4, 2026Adverse Event Without Identified Device or Use Problem

  LivaNova was informed that a patient had passed away, the cause of death and its relation to VNS was unknown at the time of the report.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 50620144 ↗
• MalfunctionAug 21, 2026Adverse Event Without Identified Device or Use Problem

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

  MAUDE report 50373731 ↗
• MalfunctionAug 13, 2026Premature Discharge of Battery; Premature Elective Replacement Indicator; Battery Problem: High Impedance

  Additional information received. The patients battery status has rebounded. Confirmed by session report. The battery rebound event was confirmed to be related to a known event cause by the impedance behaviors in the beginning of the battery's life. Internal investigation identified that in some cases, pulse generators reach the 25% battery indicator earlier than expected and later rebound without any significant programming changes. This behavior was determined to be due to an increased duration of high battery impedance during generator battery beginning-of-life. There is no evidence of a device malfunction.No other relevant information has been received to date.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50240428 ↗
• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient has an infection and will be having their generator replaced. The revision surgery was confirmed and device was replaced. 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.Device evaluation is not necessary because the reported event has been determined to be related to the functionality of the device.No other relevant information has been received to date.

  Patient problems: Skin Infection

  MAUDE report 50104466 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a LivaNova patient was currently an inpatient due to seizures. It was unknown if the seizures were related to VNS.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; Convulsion, Clonic

  MAUDE report 50019981 ↗
• DeathJul 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A VNS PATIENT WITH SEVERE EPILEPSY SECONDARY TO PITT-HOPKINS SYNDROME DIED ON (B)(6) 2026 FROM ASPIRATION-RELATED LUNG DISEASE/PNEUMONIA. THE PATIENT HAD A LONG HISTORY OF NEUROLOGICAL IMPAIRMENT AND CHRONIC DYSPHAGIA THAT PREDATED VNS THERAPY. VNS THERAPY WAS INITIATED IN 2017, WITH GENERATOR REPLACEMENTS IN 2021 AND (B)(6) 2026 DUE TO NORMAL BATTERY DEPLETION. PRIOR TO THE (B)(6) 2026 GENERATOR REPLACEMENT, THE GENERATOR HAD BEEN INACTIVE FOR APPROXIMATELY SIX MONTHS BECAUSE OF BATTERY DEPLETION. DURING THIS PERIOD, THE PATIENT'S SWALLOWING DIFFICULTIES AND COUGHING HAD ALREADY WORSENED. SETTINGS WERE ADJUSTED FOR DYSPHAGIA. IN (B)(6) 2026, THE PATIENT DEVELOPED SEVERE ASPIRATION-RELATED PNEUMONIA REQUIRING ICU ADMISSION AND SUBSEQUENTLY DIED. ALTHOUGH CLINICIANS RECOMMENDED TEMPORARILY SUSPENDING VNS STIMULATION USING THE MAGNET TO EVALUATE A POSSIBLE RELATIONSHIP BETWEEN STIMULATION AND COUGHING, THE FAMILY DECLINED. THE TREATING PHYSICIAN CONCLUDED THAT THE PATIENT'S DEATH WAS MORE LIKELY RELATED TO PROGRESSION OF PRE-EXISTING DYSPHAGIA AND ASPIRATION RISK, POTENTIALLY EXACERBATED BY INTUBATION ASSOCIATED WITH THE (B)(6) 2026 GENERATOR REPLACEMENT PROCEDUR

  Patient problems: Dysphagia/ Odynophagia; Pneumonia

  MAUDE report 25861440 ↗
• InjuryJul 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT GENERATOR EXPLANT DUE TO INFECTION AT THE GENERATOR SITE. DEVICE HISTORY RECORDS WERE REVIEWED AND THE DEVICE PASSED ALL FUNCTIONAL SPECIFICATIONS AND QUALITY TESTS AND WERE STERILIZED PRIOR TO DISTRIBUTION. DEVICE EVALUATION IS NOT NECESSARY AS REPORTED EVENTS ARE NOT RELATED TO THE FUNCTIONALITY OR DELIVERY OF THERAPY OF THE DEVICE. 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 25813677 ↗
• InjuryJul 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED FOR EXPLANT OF GENERATOR AND LEAD DUE TO 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. LATER IT WAS CONFIRMED THAT THE DEVICES WERE EXPLANTED. IT WAS REPORTED THAT THE EXPLANTED DEVICES WILL NOT BE AVAILABLE FOR RETURN TO THE MANUFACTURER DUE TO HOSPITAL PROTOCOL. PLEASE NOTE THAT DEVICE EVALUATION IS NOT NECESSARY BECAUSE THE REPORTED EVENT HAS BEEN DETERMINED TO NOT BE RELATED TO THE FUNCTIONALITY OF THE DEVICE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Medical device site infection

  MAUDE report 25782382 ↗
• InjuryJul 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS AN INPATIENT AT THE FACILITY DUE TO SEIZURES AND ACUTE MENTAL STATUS. THE PHYSICIAN WAS CONTACTED FOR ADDITIONAL INFORMATION. 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; Convulsion, Clonic; Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 25681397 ↗
• InjuryJun 24, 2026Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT IT IS SUSPECTED THAT THE VNS CAUSED HIGH GRADE AV BLOCK AND BRADYCARDIA TO 24 BPM FOR THE PATIENT. ON (B)(6) 2025, THE PATIENT EXPERIENCED EPISODES OF GOING PALE, SLURRING SPEECH, FEELING SICK AND UNSTEADY ON FEET. THIS CAUSED THE PATIENT TO SLEEP FOR SEVERAL HOURS AFTERWARDS. FURTHER DETAILS RECEIVED NOTING THAT THE PATIENT ALSO EXPERIENCED SYNCOPE BUT THERE WERE NO NOTED TRAUMATIC EVENTS OR TRIGGERS PRIOR TO THE ARRHYTHMIA. THE EVENT DID NOT OCCUR FOLLOWING A MEDICATION CHANGE, IT DID NOT CORRELATE WITH THE ON TIME AND DID NOT OCCUR WHILE PERFORMING A DIAGNOSTIC OR FOLLOWING A SETTINGS CHANGE. AN ECG WAS PERFORMED TO DIAGNOSE THE ARRHYTHMIA AND IT WAS ASSESSED AS BEING RELATED TO VNS THERAPY STIMULATION. THE PATIENT'S DEVICE WAS DISABLED ON (B)(6) 2025 AND THERE WAS NO FURTHER AV BLOCK OR BRADYCARDIA SEEN ON THE HOLTER AND ZIO PATCH RESULTS. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Bradycardia; Heart Block; Nausea; Speech Disorder; Syncope/Fainting

  MAUDE report 25612913 ↗
• InjuryJun 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INPATIENT DUE TO AN ACUTE STROKE AND SEIZURES, AND IT WAS UNKNOWN IF THE EVENT WAS RELATED TO VNS. 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; Convulsion, Clonic; Stroke/CVA

  MAUDE report 25563255 ↗
• InjuryJun 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AND HAD THEIR GENERATOR REMOVED. ADDITIONAL INFORMATION RECEIVED NOTING THAT THE INFECTION FIRST PRESENTED ON (B)(6) 2026 AND THE PATIENT UNDERWENT EXPLANT SURGERY ON (B)(6) 2026. THE CAUSE OF THE INFECTION WAS DUE TO THE PATIENT HAVING A REACTION TO THE SUTURES FROM THE VNS REPLACEMENT. 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. 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. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Medical device site infection

  MAUDE report 25546201 ↗

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-1067-2025 · Jan 3, 2025 · Open, Classified
  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
• Z-1072-2025 · Dec 12, 2024 · Open, Classified
  SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. Used for Vagus Nerve Stimulation (VNS).
• 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-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-0663-2020 · Nov 16, 2018 · Open, Classified
  VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly
• 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-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-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

…and 14 more.