VNS Therapy® PerenniaFLEX® Model 304 Lead 304-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 108 adverse event reports that list this exact device (DI 05425025750153), received between Nov 21, 2017 and May 28, 2026 — classified as 25 injuries, 83 malfunctions.

The most frequently reported specific device problem is “Fracture” (41 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 108 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2026Fracture

  IT WAS REPORTED THAT THE PATIENT HAD NORMAL IMPEDANCE PRIOR TO THEIR MRI AND HIGH IMPEDANCE POST MRI. DATA FROM THE GENERATOR WAS RECEIVED AND REVIEWED. IT WAS DISCOVERED THAT THE IMPEDANCE ONSET WAS SEEN SEVERAL MONTHS BEFORE THE MRI WAS COMPLETED. THE GENERATOR HAD SHOWED A BEHAVIOR OF INTERMITTENT IMPEDANCE ISSUES, WITH THE SYSTEM PERIODICALLY SWITCHING BETWEEN HIGH AND NORMAL IMPEDANCE VALUES. THIS IS OFTEN INDICATIVE OF A POSITIONAL LEAD FRACTURE. A PRELIMINARY REVIEW OF X-RAYS COULD NOT IDENTIFY ANY ANOMALIES OCCURRING WITHIN THE SYSTEM. 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 25318922 ↗
• MalfunctionApr 17, 2026Fracture

  IT WAS REPORTED THAT THE PATIENT WAS SEEN WITH HIGH IMPEDANCE IN FEBRUARY. X-RAYS WERE INCONCLUSIVE. THE DEVICE WAS TURNED OFF. THE PATIENT HAS BEEN SCHEDULED FOR SURGERY. NO KNOWN INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED BY THE MANUFACTURER TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24906789 ↗
• MalfunctionMar 31, 2026Fracture

  THE SUSPECTED PRODUCT WAS RETURNED DUE TO UNKNOWN REASON. INTERNAL DATA REVIEW SHOWED THAT THE DEVICE EXPERIENCING HIGH IMPEDANCE ON 01/31/2024. SINCE THE EXPLANT DATE OF THE DEVICE IS UNKNOWN. HIGH IMPEDANCE/FRACTURE OF LEAD WILL BE CAPTURED. PRODUCT ANALYSIS WAS COMPLETED AND REVIEWED; NO ANOMALIES WAS SEEN. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24743363 ↗
• MalfunctionFeb 13, 2026Fracture

  IT WAS REPORTED THAT THE PATIENT WAS SEEN IN THE ED DUE TO PAINFUL STIMULATION. THE VNS WAS CHECKED AND ALL VALUES WERE WITHIN NORMAL LIMITS. X-RAY IMAGES WERE TAKEN AND SHOWED A POSSIBLE DISCONNECTED LEAD. THE PATIENT'S DEVICE WAS DISABLED. NO KNOWN SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Discomfort

  MAUDE report 24331807 ↗
• MalfunctionJan 29, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH HIGH IMPEDANCE SHORTLY AFTER UNDERGOING A GENERATOR REPLACEMENT. 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 24218436 ↗
• MalfunctionDec 23, 2025Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THE PATIENT UNDERWENT A FULL REVISION OF THEIR VNS GENERATOR AND LEADS. THE EXPLANTED DEVICES WERE RETURNED AND RECEIVED BUT PRODUCT ANALYSIS IS CURRENTLY PENDING. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Convulsion, Clonic

  MAUDE report 23879977 ↗
• InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAS BEEN SCHEDULED TO UNDERGO A BATTERY REPLACEMENT. FURTHER DETAILS PROVIDED NOTING THAT THE PATIENT IS CONCERNED ABOUT THE ¿ANCHORS¿ THAT ARE HOLDING THE WIRE IN PLACE IN HIS NECK AND STATED THAT HE FEELS THEM ¿POP". THE PATIENT ALSO REPORTED THAT THEY CAN BE SEEN VISIBLY WHEN LOOKING AT HIS NECK. THE PATIENT WAS REFERRED FOR X-RAY IMAGING. 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 23619364 ↗
• MalfunctionNov 21, 2025Fracture; Fracture

  DURING A PROGRAMMING HISTORY DATABASE PERIODIC REVIEW, HIGH IMPEDANCE WAS OBSERVED ON 3/20/2024. ADDITIONAL INFORMATION RECEIVED NOTING THAT THE VNS WAS TURNED OFF AND THE PARENTS DO NOT WANT IT REPLACED AT THIS TIME. NO KNOWN 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 23618803 ↗
• InjuryJul 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S VNS IS STICKING OUT FROM HER NECK. THE VNS MOVEMENT HAPPENED LAST WEEK AFTER HER DAUGHTER HAD BEEN DOING JUJITSU. 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. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Pocket Erosion

  MAUDE report 22682296 ↗
• MalfunctionJul 29, 2025Fracture; Fracture

  IT WAS REPORTED THAT STATED THAT DURING AN X-RAY, THE PHYSICIAN INDICATED THAT LEAD FRACTURE WAS OBSERVED ON THE X-RAY. X-RAYS HAVE NOT BEEN RECEIVED BY THE MANUFACTURER FOR REVIEW TO DATE. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22646238 ↗
• MalfunctionJul 25, 2025Fracture; Fracture

  DURING PROGRAMMING HISTORY REVIEW, HIGH IMPEDANCE WAS SEEN. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22609111 ↗
• InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS SEEN DUE TO HYPERTROPHIC SCARRING AND IRRITATION/DISCOMFORT DUE TO MOVEMENT IN THE NECK AREA. THE PATIENT HAS BEEN SCHEDULED FOR SURGERY TO EITHER UNDERGO A REMOVAL OR REPOSITIONING OF THEIR DEVICE. 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; Chest Pain; Neck Pain; Scar Tissue

  MAUDE report 22480351 ↗
• MalfunctionJun 27, 2025Fracture; Fracture

  THE PATIENT WAS SEEN TO UNDERGO SURGERY DUE TO NORMAL LOW BATTERY. THE LEAD IMPEDANCE IN PRE-OP WAS GOOD AT 1921 OHMS. WHEN THE SURGEON OPENED THE GENERATOR POCKET TO UNSCREW THE OLD GENERATOR, HE NOTICED THE LEAD WAS SEVERED WITH THE WIRES STICKING OUT AND THE PIN DANGLING. THE SURGEON STATED HE DID NOT USE A BOVIE OR ANY OTHER EQUIPMENT THAT WOULD HAVE CUT THE LEAD. HE DECIDED TO DO A FULL REVISION, CUTTING THE OLD LEAD LEAVING LESS THAN 2 CM BEHIND. HE IMPLANTED THE NEW LEAD AND CONNECTED IT TO THE NEW GENERATOR. UPON INTERROGATION, WITH THE NEW LEAD AND NEW GENERATOR, LEAD IMPEDANCE WAS GOOD AT 1415 OHMS. THE SUSPECT DEVICE WAS NOT MADE AVAILABLE FOR RETURN. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22346406 ↗
• MalfunctionMay 23, 2025High impedance; High impedance

  IT WAS REPORTED THAT WHEN INTERROGATING THE PATIENT'S DEVICE, DIAGNOSTICS GAVE RESULTS OF HIGH IMPEDANCE. PATIENT AND PROVIDER DID NOT REPORT ANY FALL OR ACCIDENT TO THE SITE. NO SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22081821 ↗
• MalfunctionMay 23, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT WAS SEEN WITH HIGH IMPEDANCE DURING RECENT CLINICAL VISIT. THE PATIENT HAS BEEN 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 22079530 ↗
• MalfunctionApr 25, 2025Device Contamination with Body Fluid; Naturally Worn; Migration; Device Contamination with Body Fluid; Naturally Worn; Migration

  ADDITIONAL INFORMATION RECEIVED NOTING THAT THE PHYSICIAN BELIEVES THE ELECTRODES BECOMING DETACHED WAS LIKELY A CASE OF TISSUE REJECTION. DURING THE REVISION SURGERY, THERE WAS NOTHING SURROUNDING THE NERVE (ALL THREE CONTACTS WERE DETACHED). THE CAUSE OF THE BLOOD BEING FOUND INSIDE THE LEAD REMAINS UNKNOWN BUT SUSPECTED TO BE DUE TO A MICRO-FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21913531 ↗
• MalfunctionApr 22, 2025High impedance; High impedance

  IT WAS REPORTED THAT UPON INTERROGATING THE PATIENT'S DEVICE A HIGH IMPEDANCE WAS OBSERVED. NO SURGICAL INTERVENTION HAS BEEN REPORTED TO DATE. NO ADDITIONAL 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 21884692 ↗
• InjuryApr 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT THE VNS MESSED UP THEIR LEFT VOCAL CORD AFTER A LEAD REVISION, AFTER WHICH THEY WERE EXPERIENCING VOICE ALTERATION AND THROAT PAIN. GENERATOR WAS KEPT OFF FOR A PERIOD OF TIME, BUT THE EVENTS RESOLVED ON THEIR OWN. DEVICE HISTORY RECORDS WERE REVIEWED FOR THE LEAD. THE DEVICE PASSED ALL FUNCTIONAL SPECIFICATIONS AND QUALITY TESTS AND WAS STERILIZED PRIOR TO DISTRIBUTION. NO SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Paralysis

  MAUDE report 21773955 ↗
• MalfunctionApr 3, 2025Low impedance; Electrical Shorting; Low impedance; Electrical Shorting

  IMPLANT CARD RECEIVED NOTING THAT THE PATIENT UNDERWENT A FULL REVISION. THE SUSPECT DEVICE HAS NOT BEEN RECEIVED BY PRODUCT ANALYSIS TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21770267 ↗
• MalfunctionFeb 26, 2025Low impedance; Electrical Shorting; Naturally Worn; Low impedance; Electrical Shorting; Naturally Worn

  ADDITIONAL INFORMATION RECEIVED NOTING THAT THE PATIENT UNDERWENT A FULL REVISION DUE TO LOW IMPEDANCE. WHEN THE SURGEON OPENED THE POCKET FOR THE GENERATOR AND HE SAW THAT THE LEAD WAS TWISTED AND KNOTTED, INDICATING THE PATIENT WAS TWIDDLING THE DEVICE. HE THEN INSPECTED MORE OF THE LEAD SHOWING A CRACK IN THE OUTER SHEATH. THE SUSPECT DEVICE HAS NOT BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21469233 ↗
• InjuryJan 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BY THE PATIENT THAT FOLLOWING A LEAD REVISION PROCEDURE, HE HAS EXPERIENCED HEARING LOSS IN HIS LEFT EAR. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE. NO KNOWN SURGICAL INTERVENTION HAS OCCURRED TO DATE.

  Patient problems: Partial Hearing Loss; Skin Infection

  MAUDE report 21273913 ↗
• InjuryNov 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCES TWINGES OF PAIN WHEN THE VNS ACTIVATES. ADDITIONALLY, THE PATIENT EXPERIENCES MUSCLE SPASMS ASSOCIATED WITH THIS VNS STIMULATION. THE PATIENT UNDERWENT A FULL REVISION AS A RESULT. THE REASON WAS REPORTED TO BE FOR PAIN EXPLORATORY. THE SUSPECT PRODUCT HAS NOT BEEN RECEIVED BY THE MANUFACTURER TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Cramp(s) /Muscle Spasm(s); Neck Pain

  MAUDE report 20724294 ↗
• MalfunctionAug 28, 2024Fracture; Fracture

  IT WAS REPORTED THAT PATIENT HAD X-RAYS PERFORMED AND IT WAS IDENTIFIED THAT THE PATIENT'S LEAD WAS DAMAGED, THE DEVICE WAS DISABLED DUE TO THE EVENT. 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 20086770 ↗
• MalfunctionAug 21, 2024Fracture; Fracture

  IT WAS REPORTED THAT PATIENT IS SCHEDULED FOR FULL REVISION DUE TO GENERATOR MIGRATION AND BROKEN LEAD BOTH REPORTEDLY VISUALIZED FROM XRAY. THERE IS NO KNOWN TRAUMA THAT COULD HAVE CAUSED THE EVENT. THE PHYSICIAN HAS RESPONDED THAT THE CAUSE OF THE MIGRATION AND BROKEN ELECTRODE IS UNKNOWN. THE SURGERY REFERRAL WAS MADE TO PRECLUDE SERIOUS INJURY. PATIENT'S REFERRING PHYSICIAN INFO WAS PROVIDED. THE PATIENT HAD LEAD REVISION SURGERY COMPLETED. THE REPORT OF GENERATOR MIGRATION IS HOUSED IN MFR REPORT # 1644487-2024-01045. THE EXPLANTED DEVICE HAS NOT BEEN RECEIVED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20023650 ↗
• MalfunctionJun 4, 2024High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT HAD UNDERWENT BATTERY REPLACEMENT. INTRAOPERATIVELY, AFTER THE DEVICE WAS REPLACED, THE GENERATOR WAS INTERROGATED AND HIGH IMPEDANCE WAS SEEN. THE TEST RESISTOR WAS USED AND THE HIGH IMPEDANCE VALUE WAS STILL SEEN (NO CONFIRMATION ON IF SYSTEM VS GENERATOR DIAGNOSTICS WERE USED). OTHER UNSPECIFIED TROUBLESHOOTING STEPS WERE PERFORMED AND THE HIGH IMPEDANCE WAS NOT RESOLVED. THE SURGERY WAS ENDED AND THE PATIENT WAS SCHEDULED FOR A LEAD REVISION AT A LATER DATE. IT WAS LATER REPORTED THAT SYSTEM DIAGNOSTICS WAS PERFORMED WITH TEST RESISTOR & NOT GENERATOR DIAGNOSTICS. HIGH IMPEDANCE COULD NOT BE DETECTED ON PREVIOUS GENERATOR AS IT WAS AT END OF SERVICE. THE SURGEON CLAIMED THAT THEY TROUBLESHOOTED PIN INSERTION. THE SUSPECT PRODUCT REMAINS IMPLANTED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE. NO ADDITIONAL KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19458391 ↗

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