VNS Therapy PerenniaDURA Model 303 LeadRecalls & reported problems across all models

We found 2 models of VNS Therapy PerenniaDURA Model 303 Lead by Livanova USA, Inc. in the FDA's device registry (GUDID). Together they are named in 213 adverse event reports in the FDA's MAUDE database, received between Nov 10, 2017 and Aug 18, 2026 — classified as 66 injuries, 147 malfunctions.

The most frequently reported specific device problem is “Fracture” (60 reports).

1 FDA recall record name at least one of these models by its device identifier.

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

VNS Therapy PerenniaDURA Model 303 Lead recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Dec 2, 2021Class IITerminated

   A manufacturing issue may cause the silicone tubing wall thickness of vagus nerve stimulation leads to be less than the design specification. If the tubing becomes completely breached, the patient may experience discomfort or pain due to delivery of stimulation to an unintended location. If the inner lead conductor is exposed to body fluids the lead may break causing loss of therapy.

   Z-0532-2022 · Root cause: Process change control · Recall details · FDA record ↗

Most reported VNS Therapy PerenniaDURA Model 303 Lead problems

VNS Therapy PerenniaDURA Model 303 Lead models

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

• VNS Therapy® PerenniaDURA® Model 303 Lead 303-20

  Stimulator, Autonomic Nerve, Implanted (Depression)
  1 recall181 reports
• VNS Therapy® PerenniaDURA® Model 303 Lead 303-30

  Stimulator, Autonomic Nerve, Implanted (Depression)
  32 reports

Recent VNS Therapy PerenniaDURA Model 303 Lead adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2026Fracture

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Nerve Damage

  MAUDE report 50305029 ↗
• MalfunctionMay 15, 2026Therapy Delivered to Incorrect Body Area; Migration

  IT WAS REPORTED THAT THE PATIENT CAME TO THE CLINIC COMPLAINING OF DISCOMFORT DURING STIMULATION AFTER MAKING A SUDDEN MOVEMENT. AN X-RAY SHOWED THAT THE ELECTRODE HAD DISLODGED FROM THE NERVE. THE PATIENT HAS BEEN REFERRED TO NEUROSURGERY FOR REVIEW AND TO ASSESS THE POSSIBILITY OF REIMPLANTATION. 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; Neck Pain; Shock from Patient Lead(s)

  MAUDE report 25186771 ↗
• MalfunctionMay 1, 2026Low impedance; Electrical Shorting

  AN IMPLANT RECORD WAS RECEIVED INDICATING THAT A PATIENT UNDER WENT FULL REVISION DUE TO LOW IMPEDANCE. THE SUSPECT PRODUCT HAS NOT BEEN RECEIVED TO DATE. NO ADDITIONAL INFORMATION IS AVAILABLE TO DATE.

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

  MAUDE report 25058398 ↗
• MalfunctionMar 21, 2026Fracture

  IT WAS REPORTED THAT THE PATIENT WAS SEEN WITH HIGH IMPEDANCE. X-RAYS WERE TAKEN AND SHOWED NO DEFINITE DISCONTINUITY OF VNS LEADS. THE PATIENT UNDERWENT A FULL SYSTEM REPLACEMENT. SUSPECT DEVICE HAS NOT BEEN RECEIVED BY MANUFACTURER TO DATE. X-RAYS HAVE HAVE NOT BEEN RECEIVED BY MANUFACTURER TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24656589 ↗
• MalfunctionFeb 24, 2026Fracture

  IT WAS REPORTED THAT THE PATIENT WAS FOUND TO HAVE HIGH IMPEDANCE BACK IN (B)(6) 2025 AND HAD X-RAYS DONE. THE PATIENT HAD A LOT OF SCAR TISSUE, SO THE SURGEON ELECTED TO JUST CUT THE LEAD AND EXPLANT THE GENERATOR. THE EXPLANTED LEAD HAS NOT BEEN RECEIVED BY PRODUCT ANALYSIS TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24434497 ↗
• MalfunctionFeb 20, 2026High impedance

  ADDITIONAL INFORMATION RECEIVED REPORTING THAT THE PATIENT EXPERIENCED AN INCREASE IN SEIZURES (4 COMPLEX FOCAL SEIZURES PER WEEK). THERE WERE NO FALLS REPORTED FOR THE PATIENT. THE PATIENT HAD AN ELECTROMYOGRAM PERFORMED AND THE RESULTS WERE NORMAL. THERE WERE NO VISIBLE ELECTRODE FRACTURES OBSERVED ON THE CHEST X-RAYS BUT THE LEAD APPEARED TO BE TAUT DUE TO THE LACK OF A STRAIN RELIEF LOOP. THE PATIENT ALSO REPORTED THAT THE GENERATOR WAS SHIFTING POSITION. THE GENERATOR MIGRATION IS CAPTURED IN MFR. REPORT# 1644487-2026-10487. THE PATIENT THEN UNDERWENT SURGERY TO HAVE THE FULL VNS SYSTEM REMOVED. THE EXPLANTED LEAD HAS NOT BEEN RECEIVED BY PRODUCT ANALYSIS TO DATE.

  Patient problems: Convulsion, Clonic; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24408083 ↗
• MalfunctionFeb 6, 2026High impedance

  ADDITIONAL INFORMATION RECEIVED NOTING THAT NO INTERVENTION HAS BEEN PLANNED TO DATE FOR THE HIGH IMPEDANCE AS RIGHT NOW THE PATIENT'S SEIZURES ARE AT BASELINE. IT WAS ALSO CONFIRMED THAT THE LEAD PIN WAS FULLY INSERTED PAST THE SECOND CONNECTOR BLOCK, THE SETSCREW WAS FULLY TIGHTENED, AND THE IMPEDANCE WAS GOOD AT THE TIME OF IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24284955 ↗
• MalfunctionFeb 3, 2026Fracture

  IT WAS REPORTED THAT THE PATIENT WAS SEEN IN CLINIC WITH HIGH IMPEDANCE AND THE GENERATOR WAS TURNED OFF. 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 24253885 ↗
• MalfunctionJan 22, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT RECENTLY UNDERWENT SURGERY ON (B)(6) 2025 AND HIGH IMPEDANCE WAS THEN LATER OBSERVED. THE PATIENT HAD X-RAY IMAGES TAKEN AND THERE WAS NO CABLE BREAK SEEN. THE PATIENT THEN UNDERWENT AN ADDITIONAL SURGERY WHERE THE GENERATOR WAS REMOVED FROM THE POCKET AND THE IMPEDANCE WAS GOOD AND ONCE REIMPLANTED IT REMAINED GOOD. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24151690 ↗
• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LEAD REPOSITIONING SURGERY DUE TO EXTRUSION. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Pocket Erosion

  MAUDE report 23879575 ↗
• InjuryDec 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT MORE PORTIONS OF THE LEAD EXTRUDED THROUGH THE PATIENT'S SKIN AT THE NECK SITE. AS A RESULT THE PATIENT HAD THEIR ENTIRE VNS SYSTEM REMOVED. THE DEVICES WERE DISCARDED AFTER THE PROCEDURE. THE PHYSICIAN BELIEVES THIS WAS DUE TO THE INFECTION AT THE SITE THAT NEVER CLEARED UP DESPITE MULTIPLE ROUNDS OF ANTIBIOTICS. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Medical device site infection; Pocket Erosion

  MAUDE report 23728686 ↗
• MalfunctionDec 2, 2025Fracture; Fracture

  DURING PERIODIC PROGRAMMING HISTORY DATABASE REVIEW. A HIGH IMPEDANCE EVENT WAS CONFIRMED ON 09/18/2023, THE DEVICE WAS INTERROGATED (1.25 MA / 20 / 250 / 21 S / 1.8 MIN / 1.75 MA / 250 / 30 S / 1.5 MA / 250 / 30 S) AND A SYSTEM DIAGNOSTIC WAS PERFORMED. THIS RESULTED IN (OK / HIGH / 5381). NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23696425 ↗
• MalfunctionNov 26, 2025Low impedance; Electrical Shorting; Low impedance; Electrical Shorting

  LATER FOLLOW-UP REVEALED THAT NO ERROR CODES WERE SEEN IN TANDEM WITH THE LOW IMPEDANCE READING, FURTHER CONFIRMING THAT THE CAUSE OF THE LOW IMPEDANCE WAS A LEAD RELATED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23656390 ↗
• MalfunctionNov 25, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT WAS SEEN IN CLINIC WITH HIGH LEAD IMPEDANCE AND ABNORMAL OUTPUT CURRENT. A CHEST X-RAY WAS PERFORMED AND IT WAS INCONCLUSIVE. THE SCANS WERE NOT RECEIVED OR REVIEWED BY THE MANUFACTURER TO DATE. 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 23648216 ↗
• MalfunctionNov 6, 2025Corroded; Fracture; Device Contamination with Body Fluid; Naturally Worn; Corroded; Fracture; Device Contamination with Body Fluid; Naturally Worn

  THE PATIENT UNDERWENT A FULL REVISION. THE PATIENT EXPERIENCED INCREASED SEIZURES. X-RAYS WERE TAKEN AND REVEALED A LEAD BREAK. THE DEVICE HAS BEEN RETURNED AND PENDING PRODUCT ANALYSIS. X-RAYS HAVE NOT BEEN REVIEWED BY THE MANUFACTURER TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Convulsion, Clonic; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23486784 ↗

Other Livanova USA, Inc. products

• VNS Therapy PerenniaFLEX Model 304 Lead2 models · 1,722 reports
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• VNS Therapy Model 302 Lead2 models · 172 reports
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