VNS Therapy® Model 302 Lead 302-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 05425025750108), received between Apr 24, 2018 and Aug 26, 2026 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Fracture” (7 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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2026Corroded; Fracture; Device Contamination with Body Fluid; Naturally Worn

  It was reported that the patient was referred for potential full revision. It was later noted that the patient was seen by the representative and inconsistent impedance ws seen. It was later reported that on (b)(6) 2026 due to high lead impedance that had been identified more than two months earlier. During surgery, the original generator was replaced, but impedance remained elevated (approximately 5,600 ohms). After freeing and inspecting the lead within the chest pocket, impedance increased further to approximately 6,900 ohms. The lead was observed to have discoloration of the outer coating (corrosion), along with fluid accumulation and fibrotic/scar tissue in the pocket (fluid leak and tissue growth). Based on these findings, the surgeon elected to replace the lead without additional troubleshooting. Following implantation of the new lead and generator, system diagnostics showed a normal impedance of approximately 1,130 ohms. The explanted devices were retained by the hospital and subsequently discarded, making return and further analysis unavailable. The patient reportedly experienced increased seizure activity suspected to be due to high impedance.No other relevant information

  Patient problems: Convulsion, Clonic

  MAUDE report 50456878 ↗
• MalfunctionJul 2, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S VNS WAS INTERROGATED AND SHOWED HIGH LEAD IMPEDANCE AND LOW BATTERY. THE PATIENT WAS REFERRED AND UNDERWENT A FULL REPLACEMENT. THE SUSPECT DEVICE HAS NOT BEEN RECEIVED TO DATE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22387536 ↗
• MalfunctionApr 22, 2025Fracture; Fracture

  PER IMPLANT RECORD RECEIVED, IT WAS REPORTED THAT THE PATIENT UNDERWENT FULL VNS REVISION DUE TO HIGH IMPEDANCE/FRACTURE OF LEADS. SUSPECT PRODUCT HAS NOT BEEN RECEIVED BY MANUFACTURER TO DATE. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21885846 ↗
• MalfunctionFeb 11, 2025Fracture; High impedance; Incomplete or Inadequate Connection; Fracture; High impedance; Incomplete or Inadequate Connection

  X-RAYS WERE LATER RECEIVED AND REVIEWED. NO SURGICAL INTERVENTION HAS BEEN PERFORMED TO DATE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21354979 ↗
• MalfunctionNov 22, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT WAS SEEN WITH HIGH IMPEDANCE PRE-OPERATIVELY. THE GENERATOR WAS REPLACED AND THE HIGH IMPEDANCE WAS NOT RESOLVED. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE. NO SURGICAL INTERVENTION HAS BEEN REPORTED TO DATE FOR THE PATIENTS LEADS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20757640 ↗
• MalfunctionNov 8, 2024High impedance; Incomplete or Inadequate Connection; High impedance; Incomplete or Inadequate Connection

  UPDATE WAS RECEIVED THAT THE PATIENT WAS SEEN FOR SURGERY. THE SURGEON REINSERTED THE LEADS AND IMPEDANCES WERE SEEN OK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20640855 ↗
• MalfunctionJul 26, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE A FULL REVISION DUE TO HIGH IMPEDANCE. IT WAS NOTED THAT THE SUSPECT DEVICE WAS DISCARDED. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19838656 ↗
• InjuryJan 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S DEVICE SHOWED NO DIAGNOSTIC ISSUES. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Paralysis

  MAUDE report 18511328 ↗
• MalfunctionApr 24, 2023Corroded; Fracture; Corroded; Fracture

  IT WAS INITIALLY REPORTED THAT THE PATIENT WAS REFERRED FOR AN EXPLANT DUE TO UNKNOWN REASONS. THE LEAD AND GENERATOR WERE RETURNED FOR ANALYSIS. PRODUCT ANALYSIS (PA) WAS APPROVED FOR THE RETURNED LEAD. VISUAL ANALYSIS IDENTIFIED THAT THE PIN COIL WAS BROKEN AT THE END OF THE PORTION. AS THE END OF THE PIN COIL WAS BROKEN, THE APPEARANCE SUGGESTS THAT A STRESS-INDUCED FRACTURE OCCURRED. ADDITIONALLY, VISUAL ANALYSIS IDENTIFIED THAT THE RING COIL HAD TWO BROKEN STRANDS NEAR THE END PORTION, THAT WERE PITTED. DUE TO THE CONDITION OF THE STRANDS THE FRACTURE MECHANISM COULD NOT BE DETERMINED. ONE PORTION OF THE COIL HAD TWO BREAKS AND THE COIL ENDS WERE ALSO PITTED. SIMILARLY, DUE TO THE CONDITION OF THE COIL ENDS, THE FRACTURE MECHANISM COULD NOT BE DETERMINED. ANOTHER PORTION OF THE COIL WAS ALSO BROKEN AT BOTH ITS ENDS. THE APPEARANCE OF ONE OF THE ENDS OF THE PIN COIL, SUGGESTED THAT A STRESS-INDUCED FRACTURE OCCURRED. THE OTHER END WAS PITTED, THEREFORE, THE FRACTURE MECHANISM COULD NOT BE DETERMINED. CONTINUITY CHECKS WERE PERFORMED ON THE RETURNED PORTIONS OF THE LEAD, AND OTHER THAN THE CONDITIONS AND ERODED OPENINGS MENTIONED ABOVE, NO OTHER DISCONTINUITIES WERE IDENTIFIED D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16798723 ↗
• MalfunctionJul 6, 2020High impedance; High impedance

  IT WAS REPORTED BY THE NEUROLOGIST THAT THE PATIENT HAD A FALL WHERE THEY HIT THEIR HUSBAND'S SHOULDER WITH HER VNS GENERATOR. IT WAS REPORTED THAT THE PATIENT'S GENERATOR BECAME DISLODGED. THE PATIENT EXPERIENCED IMMEDIATE CHEST PAIN AND LESS SEVERE PAIN IN HER LEFT NECK. IT WAS STATED THAT VNS WAS MALFUNCTIONING. THE PATIENT GENERATOR SHOWED HIGH IMPEDANCE OF >10000 OHMS. XRAYS WERE TAKEN TO EVALUATE FOR A LEAD FRACTURE. IT WAS STATED THAT XRAYS WERE PERFORMED AND NO LEAD FRACTURES WERE OBSERVED. IT WAS REPORTED THAT PATIENT HAD BATTERY REPLACEMENT OCCUR. IT WAS REPORTED THAT THE PATIENT DID NOT HAVE THEIR LEAD REPLACED. WHEN PATIENT WOKE UP, THE PATIENT WAS NO LONGER FEELING THE PAIN. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Code Available; Pain; Seizures

  MAUDE report 10235602 ↗
• MalfunctionApr 24, 2018High impedance; High impedance

  A REVIEW OF THE AVAILABLE PROGRAMMING DATA OF THE DEVICE SHOWED THAT HIGH IMPEDANCE WAS OBSERVED. A SYSTEM DIAGNOSTIC WAS PERFORMED AND RESULTED IN HIGH IMPEDANCE. THE DEVICE WAS INTERROGATED AND THEN PROGRAMMED OFF. PRIOR DIAGNOSTICS INDICATE THAT THE IMPEDANCE WAS WITHIN NORMAL LIMITS. NO SURGICAL INTERVENTIONS ARE PLANNED. THE DEVICE WAS TURNED OFF AND THE PATIENT DID NOT ELECT TO REPAIR THE LEAD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7456446 ↗

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-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-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-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.