VNS Therapy Model 302 LeadRecalls & reported problems across all models

We found 2 models of VNS Therapy Model 302 Lead by Livanova USA, Inc. in the FDA's device registry (GUDID). Together they are named in 172 adverse event reports in the FDA's MAUDE database, received between Oct 17, 2017 and Sep 28, 2026 — classified as 8 injuries, 164 malfunctions.

The most frequently reported specific device problem is “Fracture” (122 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported VNS Therapy Model 302 Lead problems

VNS Therapy Model 302 Lead models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• VNS Therapy® Model 302 Lead 302-20

  Stimulator, Autonomic Nerve, Implanted (Depression)
  161 reports
• VNS Therapy® Model 302 Lead 302-30

  Stimulator, Autonomic Nerve, Implanted (Depression)
  11 reports

Recent VNS Therapy Model 302 Lead adverse event reports

The 15 most recent reports across all models, 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 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 ↗
• 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 ↗

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