Symmetry™ VNS Therapy Kit Model 98142Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05425025750511), received between Sep 10, 2021 and Mar 25, 2022 — classified as 3 injuries.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED EXPERIENCING A RINGING IN HIS HEAD IMMEDIATELY FOLLOWING VNS IMPLANT SURGERY. IT WAS REPORTED THAT THE RINGING DID NOT CHANGE WHEN STIMULATION WAS ENABLED/ADJUSTED. THE PATIENT ALSO REPORTED HEART EFFECTS AND SHORTNESS OF BREATH. THE PATIENT DESCRIBED THAT HE COULD FEEL WHERE HIS HEART WAS IN HIS CHEST AND THAT IT FELT LIKE THE SIZE OF HIS FIST. WHEN THE VNS WAS DISABLED THESE SIDE EFFECTS RESOLVED. THE PATIENT HAS BEEN REFERRED FOR VNS EXPLANT DUE TO THESE ADVERSE EVENTS. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Dyspnea; Headache; Unspecified Heart Problem

  MAUDE report 13904773 ↗
• InjuryDec 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING VNS IMPLANT SURGERY THE PATIENT EXPERIENCED DIFFICULTY SWALLOWING, VOICE ALTERATION, AND ASPIRATION. THE PHYSICIAN ASSESSED THAT THESE EVENTS WERE SEVERE. IT WAS NOTED THAT INTERVENTION WAS REQUIRED TO PRECLUDE SERIOUS INJURY/DEATH, ALTHOUGH THE INTERVENTION HAS NOT BEEN CLARIFIED (THE PATIENT HAS NOT GONE TO THE HOSPITAL). DIAGNOSTICS EXAMINATIONS/TESTS WERE REQUIRED. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Ambulation or Postural Difficulties; Aspiration/Inhalation; Dysphagia/ Odynophagia; Paralysis; Sore Throat

  MAUDE report 12988869 ↗
• InjurySep 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL NOTES WERE RECEIVED REGARDING THE PATIENT'S DISCHARGE PAPERS. THE NOTES INDICATE THAT THE PATIENT HAS A HISTORY OF SYNCOPE AND VISION CHANGES W/ GENERALIZED PAIN FOR YEARS PRIOR, AND THE PATIENT'S MOTHER MADE HER GO TO THE EMERGENCY DEPARTMENT DUE TO CONCERNS OF A "BAD JOB" WITH SURGERY. THE PATIENT PRESENTED TO THE ED WITH GENERALIZED WEAKNESS AND LETHARGY, AND WAS FOUND TO BE HYPOVOLEMIC/HYPOTENSIVE. THE INFECTION WORKUP RETURNED NEGATIVE, THOUGH THE PATIENT WAS NOTED TO HAVE BEEN TREATED FOR A RECENT INFECTION AT AN OUTSIDE HOSPITAL (LIKELY REPORTED SEPSIS). THE PATIENT ALSO WAS REPORTED TO HAVE HAD ELEVATED TROPONINS, AND CARDIAC CATHETERIZATION SHOWED LAD DISEASE. THE PATIENT WAS DISCHARGED WITH A CARDIAC CARE PLAN FOR LAD DISEASE. THEREFORE, IT APPEARS THAT THE HYPOTENSIVE AND HYPOVOLEMIC SYMPTOMS WERE ATTRIBUTED TO CARDIAC ISSUES, AND THE REPORTED SEPSIS WAS TREATED AT A DIFFERENT HOSPITAL/IS UNRELATED TO THE CARDIAC ISSUES ASSESSED. THERE IS NO EVIDENCE THAT THE CARDIAC ISSUES ARE ALLEGED AGAINST OR ATTRIBUTED TO THE VNS, NOR ARE THEY ASSESSED AS RELATED TO THE SEPSIS. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Sepsis

  MAUDE report 12455516 ↗

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-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-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-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.