VNS Therapy PerenniaFLEX Model 304 LeadRecalls & reported problems across all models

We found 2 models of VNS Therapy PerenniaFLEX Model 304 Lead by Livanova USA, Inc. in the FDA's device registry (GUDID). Together they are named in 1,722 adverse event reports in the FDA's MAUDE database, received between Oct 16, 2017 and Sep 28, 2026 — classified as 1 death, 393 injuries, 1,328 malfunctions.

The most frequently reported specific device problem is “Fracture” (765 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 PerenniaFLEX Model 304 Lead problems

VNS Therapy PerenniaFLEX Model 304 Lead models

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

• VNS Therapy® PerenniaFLEX® Model 304 Lead 304-20

  Stimulator, Autonomic Nerve, Implanted (Depression)
  1 death1,614 reports
• VNS Therapy® PerenniaFLEX® Model 304 Lead 304-30

  Stimulator, Autonomic Nerve, Implanted (Depression)
  108 reports

Recent VNS Therapy PerenniaFLEX Model 304 Lead adverse event reports

The 15 most recent reports across all models, 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 ↗

Other Livanova USA, Inc. products

• VNS Therapy PerenniaDURA Model 303 Lead2 models · 213 reports · 1 recall
• Perfusion Pack77 models · 95 reports · 2 recalls
• VNS Therapy Model 302 Lead2 models · 172 reports
• Cardioplegia cannula6 models · 20 reports