VNS Therapy® AspireHC® Model 105 GeneratorRecalls & reported problems

Summary

The FDA's MAUDE database contains 307 adverse event reports that list this exact device (DI 05425025750054), received between Oct 16, 2017 and May 1, 2026 — classified as 17 deaths, 180 injuries, 110 malfunctions.

The most frequently reported specific device problem is “Premature End-of-Life Indicator” (51 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. Nov 20, 2014Class IITerminated

   The recalled product was distributed with an incorrect serial number printed on the device's label.

   Z-0858-2015 · Root cause: Labeling mix-ups · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 307 reports, in the reporter's own words as published by the FDA.

• DeathMay 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PASSED AWAY. THE OBITUARY WAS LOCATED AND REVIEWED IN WHICH NO ALLEGATIONS AGAINST VNS WERE MADE. THE CAUSE OF DEATH WAS NOT REPORTED. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25060288 ↗
• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS NOW GETTING A HYPOGLOSSAL NERVE STIMULATOR IMPLANTED FOR THEIR SLEEP APNEA. IT IS UNKNOWN IF THE SLEEP APNEA IS RELATED TO THE VNS OR NOT BUT IT WAS REPORTED THAT ALL TESTING FOR SLEEP APNEA OCCURRED AFTER THE VNS WAS IMPLANTED. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Breathing-related sleep disorder

  MAUDE report 24941392 ↗
• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS IN THE HOSPITAL DUE TO INCREASED SEIZURES. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Convulsion, Clonic

  MAUDE report 24941026 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  IMPLANT CARD RECEIVED INDICATING THAT THE PATIENT UNDERWENT A GENERATOR REPLACEMENT. THE EXPLANTED DEVICE WAS NOT MADE AVAILABLE FOR RETURN.

  Patient problems: Convulsion, Clonic

  MAUDE report 24326738 ↗
• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WILL UNDERGO EXPLANT SURGERY AS THEIR DEVICE HAS BEEN OFF FOR SOME TIME AND THE PATIENT HAS LOST A SIGNIFICANT AMOUNT OF WEIGHT AND THE DEVICE IS NOW PROTRUDING. 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

  MAUDE report 24226226 ↗
• InjuryAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT STARTED TO COMPLAIN OF PAIN OVERLYING HIS LEFT CHEST AT THE VNS SITE IN (B)(6)2025. WHEN THE PATIENT WAS SEEN IN (B)(6) 2025 THE SITE APPEARED WITHOUT FLUCTUANCE OR ERYTHEMA AND IT WAS DIFFICULT TO DISCERN IF THE PATIENT HAD TRUE TENDERNESS DUE TO HIS ANXIETY OF BEING TOUCHED IN THE AREA. THE PATIENT WAS REFERRED FOR EXPLANT SURGERY. THE EXPLANT WAS CONFIRMED TO HAVE OCCURRED ON (B)(6) 2025 AND BOTH THE GENERATOR AND LEAD WERE EXPLANTED. THE EXPLANTED GENERATOR HAS NOT BEEN RECEIVED BY PRODUCT ANALYSIS TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Implant Pain

  MAUDE report 22873182 ↗
• InjuryJun 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A FULL SYSTEM REPLACEMENT DUE TO PAIN, AND TIGHTNESS IN THE NECK. DURING SURGERY THE GENERATOR WAS OBSERVED IN THE PATIENT'S SHOULDER AND THE LEAD WAS NOT CONNECTED TO THE VAGUS NERVE. THE LEAD HAD BEEN PLACED ACROSS THE BODY TO THE RIGHT SIDE OF NECK AND THEN DOWN THE RIGHT SIDE OF THE BODY. UPDATE WAS RECEIVED. THE SURGEON WAS UNABLE TO CONCLUDE WHETHER THE VNS SYSTEM MIGRATED/MOVED AND WAS NOT SURE WHAT HAD HAPPENED. PRIOR TO THE PROCEDURE X-RAYS WERE PERFORMED AND IT WAS IDENTIFIED THAT THE LEAD WAS NOT ON THE VAGUS NERVE; IMPEDANCES WERE SEEN OK. IN ADDITION, PER THE PHYSICIAN, THE REASON FOR THE PAIN WAS INCONCLUSIVE. MANUFACTURER REPORT NUMBER: 1644487-2025-10307 DOCUMENTS THE REPORT OF THE LEAD NOT CONNECTED TO THE NERVE, PAIN AND TIGHTNESS IN NECK. THIS REPORT WILL DOCUMENT THE REPORT OF THE GENERATOR MIGRATION. THE SUSPECT DEVICE HAS NOT BEEN RECEIVED 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 22365912 ↗
• InjuryJun 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CAREGIVER THAT THE PATIENT'S SEIZURES THEMSELVES ARE DIFFERENT IN NATURE. THE HCP HAD INDICATED THAT THE CAUSE OF THE CHANGE IN SEIZURE PATTERN WAS RELATED TO VNS SIMULATION. THIS REQUIRED A CHANGE IN SETTINGS (INCREASE).

  Patient problems: Convulsion, Clonic

  MAUDE report 22346645 ↗
• InjuryJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S MOTHER FELT THAT THE VNS BATTERY WAS LOW WHICH CAUSED WORSENING OF SEIZURES IN THE PATIENT. THE PATIENT'S BATTERY WAS ULTIMATELY REPLACED. THE PATIENT'S MOTHER REPORTED THAT PRIOR TO THE REPLACEMENT, THE PATIENT'S SEIZURES WORSENED TO ALMOST DAILY (3-4 GENERALIZED TONIC-CLONIC SEIZURES) A WEEK. THE SUSPECT DEVICE HAS NOT BEEN RECEIVED TO DATE. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Convulsion, Clonic

  MAUDE report 22123434 ↗
• MalfunctionMay 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RECENTLY THE PATIENT BEGAN TO EXPERIENCE AN INCREASE IN SEIZURES. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Convulsion, Clonic

  MAUDE report 22117605 ↗
• InjuryMay 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO STATUS EPILEPTICUS. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Status Epilepticus

  MAUDE report 22079887 ↗
• InjuryMar 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORT THAT THE PATIENT HAS BEEN SCHEDULED FOR DEVICE EXPLANT DUE TO DISCOMFORT. THE CAUSE OF THE PAIN IS STILL UNKNOWN AT THIS TIME. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Discomfort

  MAUDE report 21720750 ↗
• InjuryMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO STATUS EPILEPTICUS. PATIENT'S BATTERY LIFE RECENTLY ((B)(6) 2024) WAS 25 ¿ 50%. THE PHYSICIAN CANNOT SAY WHAT CONTRIBUTION VNS HAS HAD TO THE EVENT. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Status Epilepticus

  MAUDE report 21699680 ↗
• MalfunctionMar 14, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED FROM THE PATIENT THAT THEIR VNS WAS EXPLANTED DUE TO A MALFUNCTION. NO FURTHER INFORMATION WAS PROVIDED. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21607879 ↗
• InjuryFeb 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD THEIR DEVICE REMOVED AS IT WAS BOTHERING HER. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE. THE SUSPECT PRODUCT HAS NOT BEEN RECEIVED BY THE MANUFACTURER TO DATE.

  Patient problems: Insufficient Information

  MAUDE report 21432946 ↗
• InjuryJan 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT REPORTS AN INCREASE IN BREAKTHROUGH SEIZURES. THE PATIENT IS REFERRED FOR BATTERY REPLACEMENT AS A RESULT OF THIS INCREASED SEIZURES. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE. NO KNOWN SURGICAL INTERVENTION HAS OCCURRED TO DATE.

  Patient problems: Convulsion, Clonic

  MAUDE report 21282807 ↗
• InjuryDec 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE PHYSICIAN. PER THE PHYSICIAN, THE CAUSE OF THE MUSCLE SPASMS, COUGHING, VOMITING, SHORTNESS OF BREATH AND ANXIETY WAS VNS STIMULATION. THE PHYSICIAN STATED THE PATIENT'S DEVICE WAS DISABLED FOR PATIENT COMFORT ONLY. THE PATIENT'S SETTINGS WERE ALSO PROVIDED. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE. NO KNOWN SURGICAL INTERVENTION HAS OCCURRED TO DATE.

  Patient problems: Anxiety; Cough; Dyspnea

  MAUDE report 20819400 ↗
• MalfunctionNov 26, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IMPLANT CARD WAS RECEIVED REPORTING A GENERATOR REPLACEMENT. THE SUSPECT DEVICE HAS NOT BEEN RECEIVED TO DATE.

  Patient problems: Convulsion, Clonic

  MAUDE report 20785187 ↗
• InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SUSPECT DEVICE WAS RECEIVED INTO PRODUCT ANALYSIS. PRODUCT ANALYSIS WAS COMPLETED ON THE SUSPECT DEVICE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Convulsion, Clonic

  MAUDE report 20507365 ↗
• InjuryOct 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S SEIZURES HAVE GOTTEN MUCH WORSE WITH THE VNS. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Convulsion, Clonic

  MAUDE report 20482355 ↗
• InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS THEN REPORTED THAT THE PATIENT'S DEVICE WAS REMOVED AS IT WAS CAUSING PAIN. IT HAD BEEN OFF FOR OVER TWO YEARS. THE EXPLANTED DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER, INDICATING IT WAS LIKELY DISCARDED. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Discomfort

  MAUDE report 20016730 ↗
• DeathJun 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD THE VNS AND IT DIDNT WORK FOR HIM AND HE PASSED AWAY. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Convulsion, Clonic

  MAUDE report 19634984 ↗
• InjuryJun 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING SENSORY ISSUES DUE TO THE PRESENCE OF THE VNS. THEIR VNS IS TO BE REMOVED AS A RESULT. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Implant Pain

  MAUDE report 19605013 ↗
• DeathMay 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RECENTLY PASSED AWAY. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19342619 ↗
• InjuryApr 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS CURRENTLY HOSPITALIZED DUE TO SEIZURES. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Convulsion, Clonic

  MAUDE report 19144917 ↗

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-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-0663-2020 · Nov 16, 2018 · Open, Classified
  VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly
• 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-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.