VNS Therapy® Model 302 Lead 302-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 161 adverse event reports that list this exact device (DI 05425025750092), received between Oct 17, 2017 and Sep 28, 2026 — classified as 6 injuries, 155 malfunctions.

The most frequently reported specific device problem is “Fracture” (115 reports).

30 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 161 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026High impedance

  It was reported that the patient recently had a generator replacement. High impedance was seen at their most recent clinic visit. The patient is to have x-ray taken and has been referred to neurosurgery.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 50916878 ↗
• InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that months after undergoing a generator replacement, the patient was found to have their lead exposed and an infection with purulent discharge. The patient underwent surgery where the surgeon found that the lead was exposed through the wound, and the lead was found to be infected with pus. A culture was taken and it was found to be positive for staphylococcus. There was no evidence of an infection found for the generator. Both the generator and lead were explanted.The device history records for the lead were reviewed. The lead 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Medical device site infection; Pocket Erosion

  MAUDE report 50163962 ↗
• MalfunctionJul 13, 2026High impedance

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

  MAUDE report 25796874 ↗
• MalfunctionJun 30, 2026Fracture

  IT WAS REPORTED THAT THE PATIENT RECEIVED A TOTAL REVISION BATTERY REPLACEMENT TODAY DUE TO HIGH LEAD IMPEDANCE. THE SURGEON REMOVED 100% OF THE LEAD/ELECTRODES AND REPLACED VNS SYSTEM. THE HOSPITAL WOULD NOT ALLOW THE GENERATOR OR LEAD TO SEND BACK FOR EVALUATION. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25666753 ↗
• MalfunctionJun 17, 2026Fracture

  IT WAS REPORTED THAT THE PATIENT WAS SEEN WITH HIGH IMPEDANCE. THE PATIENT HAS BEEN REFERRED FOR REVISION. 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 25534755 ↗
• MalfunctionMay 15, 2026Low impedance; Electrical Shorting

  IT WAS REPORTED A PATIENT REPORTED NO LONGER BEING ABLE TO FEEL THEIR VNS STIMULATION. THE PATIENT'S VNS DISPLAYED LOW IMPEDANCE UPON INTERROGATION. THE PATIENT WAS REFERRED FOR EXPLORATORY SURGERY. NO KNOWN SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO ADDITIONAL RELEVANT INFORMATION IS AVAILABLE TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25191997 ↗
• MalfunctionMay 5, 2026Fracture

  IT WAS REPORTED THAT THE PATIENT WAS SEEN WITH HIGH IMPEDANCE AND LOW OUTPUT. AP CHEST X-RAYS WERE RECEIVED ON (B)(6) 2026 AND REVIEWED BY CQE (B)(6) ON (B)(6) 2026 AND APPROVED BY CQE (B)(6) ON (B)(6) 2026. THE X-RAYS WERE PROVIDED AFTER A REPORT OF HIGH IMPEDANCE AND LOW OUTPUT CURRENT. GENERATOR PLACEMENT WAS OBSERVED TO BE ACCORDING TO LABELING, WITH THE GENERATOR SITTING IN THE LEFT CHEST, BELOW THE CLAVICLE. BASED ON THE IMAGES PROVIDED, THE FEEDTHROUGH WIRES WERE INTACT, AND THE LEAD PIN IS FULLY INSERTED AS THE END OF THE PIN CAN BE SEEN PAST THE SECOND CONNECTOR BLOCK. THE ENTIRE PORTION OF THE LEAD CAN BE VISUALIZED, AND A STRAIN RELIEF LOOP AND BEND ARE PRESENT, BOTH PLACED PER LABELING. ONLY ONE TIE DOWN IS VISIBLE, PLACED LATERALLY FROM THE ANCHOR TETHER. A PORTION OF THE LEAD WAS VISUALIZED TO BE BEHIND THE GENERATOR. THE VISIBLE PORTIONS OF THE LEAD WERE ASSESSED FOR FRACTURE AND DISCONTINUITIES; HOWEVER, NONE WERE NOTED. BASED ON THE X-RAYS RECEIVED, THE CAUSE OF THE MALFUNCTIONS COULD NOT BE DETERMINED; HOWEVER, ANY FRACTURES OR MICROFRACTURES ON THE PORTIONS OF THE LEAD THAT WERE NOT VISIBLE CANNOT BE RULED OUT. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED BY T

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

  MAUDE report 25076688 ↗
• MalfunctionMay 1, 2026Low impedance; Electrical Shorting; Naturally Worn

  IT WAS REPORTED THAT DURING A PATIENT'S GENERATOR REPLACEMENT, LOW IMPEDANCE WAS OBSERVED AFTER THE NEW GENERATOR WAS ATTACHED TO THE PATIENT'S LEADS. THE SURGEON INDICATED THEY OBSERVED A FRACTURE IN THE PLASTIC OF THE LEAD. IT IS UNKNOWN IF THE FRACTURE WAS LIMITED TO THE OUTER TUBING OR IF INNER AND OUTER TUBING WERE FRACTURED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS RESCHEDULED FOR LEAD REVISION AND THAT THE PATIENT'S LEADS WERE REPLACED. THE SUSPECT PRODUCT HAS NOT BEEN RECEIVED BY THE MANUFACTURER TO DATE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25058683 ↗
• MalfunctionApr 25, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT WAS SEEN WITH HIGH IMPEDANCE DURING A GENERATOR REPLACEMENT. LEAD IMPEDANCE WAS WITHIN NORMAL LIMITS PRIOR TO THE PROCEDURE, HOWEVER LEAD IMPEDANCE WAS HIGH AFTER THE NEW GENERATOR WAS PLACED. THE SURGEON DISCONNECTED THE LEAD FROM THE NEW GENERATOR, AND CHECKED WITH THE OLD GENERATOR AND HIGH IMPEDANCE WAS OBSERVED AGAIN. THE PATIENT WAS SCHEDULED FOR X-RAYS. 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 24991264 ↗
• MalfunctionApr 17, 2026Fracture

  IT WAS REPORTED A PATIENT WAS SEEN WITH HIGH IMPEDANCE. THE PATIENT REPORTED NOT EXPERIENCING ANY TRAUMA TO THE AREA OF THEIR VNS. NO 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 24916802 ↗
• MalfunctionMar 26, 2026Fracture

  THE PATIENTS VNS WAS RECEIVED BY MANUFACTURER WITH NO REASON FOR EXPLANT. IT IS UNKNOWN WHEN OR WHY THE DEVICE WAS EXPLANTED AND RETURNED. GENERATOR PRODUCT ANALYSIS WAS PREFORMED AND HIGH IMPEDANCE WAS SEEN. SINCE THE EXPLANT DATE WAS NOT PROVIDED, THE HIGH IMPEDANCE WILL BE CAPTURED. PRODUCT ANALYSIS OF THE LEAD WAS COMPLETED. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24698410 ↗
• MalfunctionMar 21, 2026Fracture

  IT WAS REPORTED THAT THE PATIENT WAS SEEN IN CLINIC WITH HIGH IMPEDANCE. THE PATIENT HAS BEEN REFERRED FOR X-RAYS. 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 24656588 ↗
• MalfunctionMar 20, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT'S BATTERY COULD NOT BE INTERROGATED IN PREOP DUE TO BATTERY DEPLETION. HIGH IMPEDANCE WAS OBSERVED AFTER THE BATTERY WAS REPLACED. THE PATIENT WILL BE REFERRED FOR LEAD REVISION. 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 24656548 ↗
• MalfunctionMar 20, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT RECEIVED A BATTERY REPLACEMENT. THE IMPEDANCE AFTER SURGERY WAS NORMAL 2992 OHMS ON (B)(6) 2026. A DAY AFTER THE BATTERY REVISION, HIGH IMPEDANCE OF OVER 10000 OHMS WAS SEEN ON (B)(6) 2026. AN EXPLORATORY SURGERY WAS PERFORMED WHERE GENERATOR DIAGNOSTICS WERE PREFORMED USING THE TEST RESISTOR (FUNCTIONING AS INTENDED). TROUBLESHOOT FOR THE HIGH IMPEDANCE WAS ALSO PREFORMED SUCH AS REINSERT THE LEAD PIN INTO THE GENERATOR RECEPTACLE. THE PHYSICIAN ATTEMPTED TO REPOSITION AND REARRANGE THE LEAD IN THE POCKET AND NECK AREA TO ENSURE THAT THE LEAD WAS NOT TWISTED OR KINKED. THE LEAD WAS ALSO INSPECTED FOR POSSIBLE DAMAGE; HOWEVER, NO OBVIOUS EVIDENCE OF DAMAGE WAS OBSERVED. HIGH IMPEDANCE STILL PERSISTED. THE PATIENT WAS THEN CLOSED AND NO LEAD WAS REPLACED. X-RAYS WERE PERFORMED. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24656048 ↗
• MalfunctionMar 11, 2026Fracture; High impedance

  FURTHER UPDATE BY THE TREATING PHYSICIAN REVEALED THAT THERE WAS NO REPORTED TRAUMA TO DEVICE AREA OR MANIPULATION. PATIENT UNDERWENT LEAD REPLACEMENT SURGERY. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24568059 ↗
• MalfunctionMar 10, 2026Fracture; Device Contamination with Body Fluid; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY DUE TO SEVERE ANOXIC BRAIN INJURY, GENERALIZED SEIZURES, INTRACTABLE STATUS EPILEPTICUS AND LENNOX-GASTAUT SYNDROME. THE DEVICES WERE EXPLANTED AND RETURNED FOR PRODUCT ANALYSIS. A FAILURE WAS OBSERVED DURING THE ANALYSIS OF THE RETURNED LEAD, IT IS NOT BELIEVED TO BE RELATED TO THE REPORTED DEATH. THE REPORTED DEATH IS INVESTIGATED AND REPORTED ON MANUFACTURING REPORT NUMBER 1644487-2025-10713. THIS REPORT WILL CAPTURE THE OBSERVED LEAD ISSUES. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24564168 ↗
• MalfunctionMar 6, 2026High impedance

  HIGH IMPEDANCE WAS OBSERVED AFTER A GENERATOR REPLACEMENT. THE PIN WAS REMOVED AND RE-INSERTED BUT HIGH IMPEDANCE PERSISTED. THE NEW GENERATOR WAS TESTED WITH A TEST RESISTOR PIN AND GENERATOR DIAGNOSTICS CAME BACK WITHIN NORMAL LIMITS. THE PHYSICIAN DECIDED TO REPLACE THE LEAD IN A SECONDARY SURGICAL PROCEDURE. THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24536189 ↗
• MalfunctionMar 2, 2026Impedance Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEAD REVISION DUE TO HIGH IMPEDANCE/LEAD FRACTURE. SUSPECT DEVICE HAS NOT BEEN RECEIVED BY MANUFACTURER TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24478575 ↗
• MalfunctionFeb 24, 2026Fracture

  IT WAS REPORTED VIA IMPLANT CARD THAT THE PATIENT UNDERWENT BATTERY REPLACEMENT DUE TO HIGH IMPEDANCE. IT WAS LATER REPORTED THAT HIGH IMPEDANCE WAS SEEN PRIOR TO BATTERY REVISION. THE LEAD WAS REPLACED AND HIGH IMPEDANCE WAS RESOLVED. IT WAS ALSO NOTED THAT THE PATIENT DID NOT EXPERIENCE ANY TRAUMA AROUND THE VNS SITES. NO X-RAYS WERE PERFORMED FOR THIS EVENT. THE SUSPECTED DEVICE WAS NOTED TO BE DISCARDED. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24434064 ↗
• MalfunctionFeb 18, 2026Fracture

  IT WAS REPORTED THAT THE PATIENT WAS TO UNDERGO A FULL REVISION FOR AN MRI. THE REASON WAS LATER DETERMINED DURING THE EXPLANT PROCEDURE THAT HIGH IMPEDANCE WAS OBSERVED. THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24378236 ↗
• MalfunctionFeb 4, 2026Fracture; Device Contamination with Body Fluid; Naturally Worn

  PRODUCT ANALYSIS WAS COMPLETED ON THE RETURNED GENERATOR ASSOCIATED WITH THE CASE. A REVIEW OF THE DATA FROM THE GENERATOR SHOWED HIGH IMPEDANCE WAS SEEN EARLIER THAN PREVIOUSLY REPORTED. NO OTHER ANOMALIES WERE OBSERVED IN THE PRODUCT ANALYSIS OF THE GENERATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24257033 ↗
• MalfunctionJan 23, 2026Fracture

  IT WAS REPORTED THAT HIGH IMPEDANCE WAS SEEN DURING A GENERATOR REPLACEMENT AFTER THE NEW GENERATOR WAS CONNECTED. UPON LEAD INSPECTION, THERE WAS A VISIBLE FRACTURE. THE LEAD WAS REPLACED. THE SUSPECT DEVICE HAS NOT BEEN RECEIVED BY MANUFACTURER TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24168942 ↗
• MalfunctionJan 9, 2026Corroded; High impedance

  ADDITIONAL INFORMATION RECEIVED. IT WAS NOTED THAT THE PATIENTS LEAD WAS REPLACED. THE SUSPECTED DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Discomfort

  MAUDE report 24028329 ↗
• MalfunctionJan 1, 2026Fracture

  IT WAS LATER REPORTED THAT THE PATIENT UNDERWENT LEAD REPLACEMENT. THE EXPLANTED LEAD HAS NOT BEEN RETURNED TO THE MANUFACTURER TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23939601 ↗
• MalfunctionDec 19, 2025Fracture; Fracture

  ADDITIONAL INFORMATION WAS RECEIVED THAT HIGH IMPEDANCE FIRST OCCURRED A DAY EARLIER THAN WHAT WAS INITIALLY REPORTED, WITH FOUR SEPARATE READINGS OF HIGH IMPEDANCE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED BY THE MANUFACTURER TO DATE. NO SURGICAL INTERVENTION HAS BEEN REPORTED TO THE MANUFACTURER TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23854321 ↗

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-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

…and 15 more.