VNS Therapy® PerenniaFLEX® Model 304 Lead 304-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,614 adverse event reports that list this exact device (DI 05425025750139), received between Oct 16, 2017 and Sep 28, 2026 — classified as 1 death, 368 injuries, 1,245 malfunctions.

The most frequently reported specific device problem is “Fracture” (724 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 1,614 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Discomfort

  MAUDE report 50924251 ↗
• MalfunctionSep 25, 2026Fracture

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

  MAUDE report 50904315 ↗
• MalfunctionSep 24, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885781 ↗
• MalfunctionSep 24, 2026Fracture

  Implant card was received reporting a full system replacement due to lead fracture/high impedance.No other relevant information has been received to date.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883254 ↗
• MalfunctionSep 23, 2026Fracture

  It was reported that while re-enabling a device following an MRI the physician observed that the patient had a lead impedance over 8000 Ohms.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 50870241 ↗
• MalfunctionSep 17, 2026Fracture

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

  MAUDE report 50808670 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Dysphagia/ Odynophagia; Paresis

  MAUDE report 50805234 ↗
• MalfunctionSep 17, 2026Fracture

  During periodic internal data review high impedance/fracture was seen.No other relevant information has been received to date.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50804631 ↗
• MalfunctionSep 17, 2026High impedance

  It was reported that the patients output current was not being delivered, and lead impedance was >9,000 ohms, suggesting a possible lead discontinuity or hardware malfunction. Chest and neck X-rays were ordered to assess for lead damage or fracture. The patient reported recent attendance at a fair where ride restraints may have applied pressure over the implant site, potentially contributing to device- or lead-related trauma. Due to the diagnostic findings and concern for lead failure, surgical exploration with possible lead revision or replacement was scheduled.It was later noted that the x-rays were not available for review. The provider noted that the pin was fully inserted and that there was no visible lead break.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 50804266 ↗
• MalfunctionSep 16, 2026Fracture

  The patient underwent a full revision due to high lead impedance. The explanted lead 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 50789939 ↗
• MalfunctionSep 16, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50788461 ↗
• MalfunctionSep 15, 2026Fracture

  The patient was seen in clinic and presented with high lead impedance. The patient has since been referred for a full revision.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; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50772063 ↗
• MalfunctionAug 18, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50306583 ↗
• MalfunctionAug 14, 2026Corroded; Fracture; High impedance

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

  MAUDE report 50261117 ↗
• MalfunctionJul 17, 2026Fracture

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

  MAUDE report 25860570 ↗
• MalfunctionJul 13, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25798222 ↗
• InjuryJul 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED FOR VNS WIRE REPOSITIONING FOR UNKNOWN REASON. ADDITIONAL INFORMATION RECEIVED. PER PHYSICIAN, THE REVISION WAS PERFORMED BECAUSE ANCHOR WAS CLOSE TO SURFACE OF SKIN AND CAUSED PAIN AND WORRY THAT IT COULD POTENTIALLY OVERTIME EXTRUDE THROUGH THE SKIN. IMPLANT WOULD DRIFT UP TOWARDS LEFT SHOULDER WHEN SHE LAID DOWN CAUSING DISCOMFORT. THE INTERVENTION WAS INDICATED TO PRECLUDE SERIOUS INJURY. THIS REPORT WILL CAPTURE ADVERSE EVENTS ON THE LEAD. PROTRUSION AND NECK PAIN. ALL OTHER ADVERSE EVENT ON THE GENERATOR WILL BE CAPTURED IN A SEPARATE REPORT. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

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

  MAUDE report 25681744 ↗
• MalfunctionJun 29, 2026Fracture

  IT WAS REPORTED THAT THE PATIENT WAS SEEN WITH HIGH IMPEDANCE OF OVER 9000 OHMS. PATIENT HAS BEEN REFERRED FOR REPLACEMENT ALONG WITH X-RAYS, AND DEVICE DISABLEMENT. 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 25659325 ↗
• MalfunctionJun 25, 2026Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT FULL REVISION DUE TO HIGH IMPEDANCE AND LOW BATTERY. THE EXPLANTED 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 25627332 ↗
• MalfunctionJun 23, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT WAS SEEN WITH HIGH IMPEDANCE. THE PATIENT AND THE PATIENT'S MOTHER HAD DECLINED ANY RECENT FALLS OR TRAUMA TO THE AREA. THE LEAD IMPEDANCE WAS >=9,000 OHMS WITH A WARNING SIGN. IT WAS LATER REPORTED THAT NO X-RAYS WERE PREFORMED AND THAT REVISION SURGERY IS PLANNED. 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 25599958 ↗
• MalfunctionJun 17, 2026High impedance

  DURING PRODUCT ANALYSIS HIGH IMPEDANCE WAS SEEN ON (B)(6) 2025 WITH VALUES OF 13655 OHMS AND 22014 OHMS. AS THE EXPLANT DATE OF THE DEVICE IS NOT KNOWN HIGH IMPEDANCE IS BEING INVESTIGATED AS IF IT OCCURRED WHILE DEVICE WAS IMPLANTED. NO OTHER 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 25534033 ↗
• MalfunctionJun 17, 2026High impedance

  PATIENT PREVIOUSLY HAD FULL REVISION, IMPEDANCE MEASURED 2100 OHMS POST OPERATIVELY. IT WAS THEN REPORTED THAT PATIENT WAS SEEN WITH HIGH IMPEDANCE >9000 OHMS DURING FOLLOW UP. PHYSICIAN STATED THAT PATIENT IS EXPERIENCING AN INCREASE IN SEIZURES OF ABOUT 7 TO 10 A DAY DUE TO DIMINISHED EFFICACY AS A RESULT OF HIGH IMPEDANCE, AND IS SUSPECTED TO NOT BE RECEIVING ANY STIMULATION AT ALL. 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 25532222 ↗
• MalfunctionJun 17, 2026High impedance

  INITIALLY DEVICE WAS RECEIVED BY THE PRODUCT ANALYSIS TEAM WITH NO EXPLANT INFORMATION. PA WAS APPROVED FOR THE GENERATOR, VISUALLY THE DEVICE OBSERVATIONS ARE MOST LIKELY ASSOCIATED WITH MANIPULATION OF THE DEVICE DURING THE IMPLANT/EXPLANT PROCEDURES. HIGH IMPEDANCE WAS OBSERVED ON THE DEVICE ON (B)(6) 2025, SINCE THE DATE OF EXPLANT IS NOT KNOWN THIS WILL BE CAPTURED AS HIGH IMPEDANCE CASE. PRODUCT ANALYSIS WAS PERFORMED ON THE LEAD THE LEAD THE ENDS OF THE OUTER/INNER TUBES AND COILS WERE CUT. INCISIONS WERE MADE POST DECONTAMINATION TO ALLOW FOR CONTINUITY CHECKS. FUNCTIONAL ANALYSIS CONTINUITY CHECKS ON THE RETURNED PORTION WERE GOOD , NO OPEN CIRCUIT CONDITIONS. NO DISCONTINUITIES WERE IDENTIFIED DURING THE CONTINUITY CHECK. 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 25530615 ↗
• InjuryJun 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A PHYSICIAN THAT THE PATIENT IS PRESENTING WITH VOCAL CORD PARALYSIS RELATED TO HIS VNS IMPLANT. THE PHYSICIAN STATED THAT SHE INTENDS TO PERFORM A SURGICAL PROCEDURE TO APPROXIMATE THE VOCAL CORDS. ADDITIONAL INFORMATION RECEIVED NOTING THAT THE VOCAL CORD PARALYSIS IS ON THE LEFT VOCAL CORD AND IT OCCURRED AFTER VNS IMPLANT. THE PHYSICIAN BELIEVES THE PARALYSIS IS RELATED TO THE IMPLANT SURGERY AND DID NOT INDICATE VNS STIMULATION. SETTINGS AND DIAGNOSTICS WERE NOT PROVIDED. 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; Paralysis

  MAUDE report 25522681 ↗
• MalfunctionJun 9, 2026Fracture

  DURING PROGRAMMING HISTORY DATABASE REVIEW HIGH IMPEDANCE WAS OBSERVED ON THE PATIENT ON (B)(6) 2025 AND AGAIN ON (B)(6) 2025. 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 25448713 ↗

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-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-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-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-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-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 15 more.