VNS Therapy® PerenniaDURA® Model 303 Lead 303-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 181 adverse event reports that list this exact device (DI 05425025750115), received between Nov 10, 2017 and Aug 18, 2026 — classified as 51 injuries, 130 malfunctions.

The most frequently reported specific device problem is “Fracture” (55 reports).

1 FDA recall record name this device's identifier.

29 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.

Recalls naming this device

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 problems

Recent adverse event reports

The 25 most recent of 181 reports, 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 ↗
• MalfunctionSep 15, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT WAS SEEN IN CLINIC WITH HIGH IMPEDANCE. THE PATIENT WAS BEING REFERRED TO THE SURGEON FOR A 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 23058843 ↗
• MalfunctionSep 12, 2025High impedance; High impedance

  THE PATIENT WAS SEEN IN CLINIC AND PRESENTED WITH HIGH IMPEDANCE. THE PATIENT HAS SINCE BEEN REFERRED FOR SURGERY. ADDITIONAL INFORMATION RECEIVED NOTING THAT THE PATIENT HAS NOT EXPERIENCED ANY RECENT TRAUMA OR MANIPULATION, AND X-RAYS WERE NOT TAKEN. 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 23038434 ↗
• MalfunctionAug 28, 2025High impedance; High impedance

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT UNDERWENT A LEAD REVISION DUE TO THE HIGH IMPEDANCE REPORTED. THE EXPLANTED LEAD HAS NOT BEEN RECEIVED TO DATE.

  Patient problems: Convulsion, Clonic; Depression

  MAUDE report 22913770 ↗
• MalfunctionAug 1, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING LEFT CERVICAL PAIN ASSOCIATED WITH STIMULATION. THE PATIENT'S DEVICE WAS THEN LATER PERMANENTLY DISABLED DUE TO A SUSPECTED LEAD DISCONTINUITY. NO KNOWN SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Implant Pain

  MAUDE report 22688508 ↗
• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS REFERRED FOR EXPLANT AS THEIR LEADS ARE COMING OUT OF THE SURGICAL SITE AT THE NECK AND ARE NOW EXPOSED. DEVICE HISTORY RECORDS WERE REVIEWED FOR THE GENERATOR AND LEAD. THE GENERATOR AND LEAD PASSED ALL SPECIFICATIONS PRIOR TO DISTRIBUTION. THE GENERATOR AND LEAD WERE HP STERILIZED. IT WAS LATER REPORTED THAT THE PATIENT WAS EXPLANTED ON (B)(6) 2025. IT IS UNKNOWN WHAT DEVICE(S) WERE REMOVED. BASED ON THE CONTEXT OF THE COMPLAINT IT IS ASSUMED THAT THE EXPLANT IS IN REFERENCE TO THE LEAD. DEVICE EVALUATION IS NOT NECESSARY BECAUSE THE REPORTED EVENT HAS BEEN DETERMINED TO NOT BE RELATED TO THE FUNCTIONALITY OF THE DEVICE. THE SUSPECT PRODUCT HAS NOT BEEN RECEIVED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Pocket Erosion

  MAUDE report 22669438 ↗
• MalfunctionJul 29, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S VNS WAS INTERROGATED AND FOUND TO HAVE HIGH IMPEDANCE. 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 22646252 ↗
• MalfunctionJul 25, 2025Fracture; Fracture

  DURING A REVIEW OF PROGRAMMING HISTORY, HIGH IMPEDANCE WAS SEEN FOR PATIENT. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22610538 ↗
• MalfunctionJul 19, 2025Low impedance; No Apparent Adverse Event; Low impedance; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PAINFUL STIMULATION AND MUSCLE SPASMS OF THE JAW, EYES, FOREHEAD, AND NECK. THE PATIENT REPORTEDLY FELT LIKE HER HEAD AND EYES WERE BULGING. THE PHYSICIAN DISABLED THE DEVICE BUT THE PATIENT REPORTEDLY FELT STIMULATION DESPITE THE DEVICE DISABLEMENT. THE PHYSICIAN REPORTEDLY SAW A LOW IMPEDANCE WARNING MESSAGE DESPITE LEAD IMPEDANCES VALUES BEING WITHIN NORMAL LIMITS. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND WAS SEEN BY THE EPILEPSY NURSES. THE PATIENT'S VNS WAS LATER RE-ENABLED. DIAGNOSTICS ARE WITHIN NORMAL LIMITS. A REVIEW OF DEVICE HISTORY RECORDS SHOWED THAT THE LEAD PASSED QUALITY CONTROL INSPECTION AND WAS STERILIZED PRIOR TO DISTRIBUTION. NO SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Cramp(s) /Muscle Spasm(s); Discomfort; Neck Pain; No Clinical Signs, Symptoms or Conditions; Shock from Patient Lead(s)

  MAUDE report 22550386 ↗
• MalfunctionJun 16, 2025Low impedance; Device Contamination with Body Fluid; Electrical Shorting; Naturally Worn; Low impedance; Device Contamination with Body Fluid; Electrical Shorting; Naturally Worn

  PRODUCT ANALYSIS WAS COMPLETED ON THE NON-SUSPECT GENERATOR PRODUCT. INTERNAL GENERATOR DATA WAS REVIEWED AND ADDITIONAL LOW IMPEDANCE VALUES WERE SEEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22214993 ↗
• MalfunctionJun 3, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT WAS SEEN WITH A HIGH IMPEDANCE. 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 22134063 ↗

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-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-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-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-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-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
• Z-0659-2016 · Dec 18, 2015 · Terminated
  VNS Therapy AspireSR Generator Model 106. Indicated for use as an adjunctive therapy in reducing the frequency of seizures.

…and 14 more.