Vivistim® 1001Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10810041430028), received between May 10, 2023 and Sep 25, 2026 — classified as 34 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Voice alteration

  MAUDE report 50905110 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Medical device site infection; Wound Dehiscence

  MAUDE report 50904080 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Voice alteration

  MAUDE report 50892685 ↗
• InjuryAug 22, 2026Adverse Event Without Identified Device or Use Problem

  The patient was implanted with the Vivistim System on (b)(6) 2024. On (b)(6) 2026, patient indicated to Mobia personnel that the device had been explanted approximately one year ago. Follow-up with the implanting site indicated date of explant was on (b)(6) 2025. Patient denied any concerns that the device wasn't working and denied any discomfort when using the device. Patient did not complete the therapy protocol due to non-compliance and discharge by the clinic. No Mobia personnel were present at the explant and no explanted device components returned for evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50384218 ↗
• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

  The patient was implanted with the Vivistim System on (b)(6) 2026. On (b)(6) 2026 the patient reported to the therapy development specialist ((b)(6) employee) at their first therapy protocol session that they had experienced stroke-like symptoms since coming out of the implant surgery, and were admitted to the hospital over the previous weekend from (b)(6) 2026. The implanted device remained off during this period before therapy initiation. Patient reported that CT imaging had been performed which identified a new and progressed occlusion. MRI imaging was reportedly planned but has not occurred to date to manufacturer's knowledge. As of date of report the patient is progressing through the therapy protocol and reported the deficits they experienced post-surgery had improved. No additional symptoms or interventions have been reported by patient or provider team since therapy protocol initiation on (b)(6) 2026.

  Patient problems: Obstruction/Occlusion; Stroke/CVA

  MAUDE report 50216585 ↗
• InjuryJul 1, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS IMPLANTED WITH THE VIVISTIM® SYSTEM ON (B)(6) 2025. THE PATIENT COMPLETED THE THERAPY PROTOCOL IN (B)(6) 2026 WITHOUT REPORTING VOICE-RELATED COMPLAINTS DURING TREATMENT. IN (B)(6) 2026, THE TREATING SPEECH-LANGUAGE PATHOLOGIST (SLP) REPORTED THAT THE PATIENT WAS EXPERIENCING VOICE CHANGES, INCLUDING DECREASED VOCAL VOLUME, WITH UNILATERAL VOCAL CORD INVOLVEMENT. THE PATIENT REPORTED THAT THE VOICE CHANGES HAD NOT IMPROVED BUT HAD NOT WORSENED SINCE THE IMPLANT PROCEDURE. THE PATIENT PARTICIPATED IN SLP THERAPY, WITH MILD IMPROVEMENT REPORTED; HOWEVER, NO DEVICE PROGRAMMING CHANGES OR STIMULATION SETTING ADJUSTMENTS WERE MADE FOLLOWING COMPLETION OF THE THERAPY PROTOCOL. ON JUNE 2, 2026, THE MANUFACTURER BECAME AWARE THAT THE PATIENT HAD INFORMED THE MOBIA MEDICAL THERAPY DELIVERY SPECIALIST ON (B)(6) 2026, THAT THE PATIENT HAD PREVIOUSLY UNDERGONE A VOCAL CORD INJECTION PERFORMED BY AN OTOLARYNGOLOGIST WITHOUT RESOLUTION OF SYMPTOMS AS OF (B)(6) 2026. THE PATIENT WAS ADVISED TO RETURN EVERY THREE MONTHS FOR REPEAT INJECTIONS BUT ELECTED NOT TO CONTINUE DUE TO THE DISCOMFORT ASSOCIATED WITH THE PROCEDURE. AT THE TIME OF THIS REPORT, THE PATIENT'S VOICE CHANGES PERSI

  Patient problems: Paresis

  MAUDE report 25680970 ↗
• InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS IMPLANTED WITH THE VIVISTIM SYSTEM ON (B)(6) 2026. ON (B)(6) 2026, DURING A REHABILITATION THERAPY SESSION WITH STIMULATION, THE PATIENT REPORTED GENERALIZED FATIGUE FOLLOWED BY A SEIZURE. THE SEIZURE LASTED APPROXIMATELY 1-2 MINUTES WHILE THE PATIENT WAS SEATED. FOLLOWING THE EVENT, THE PATIENT WAS TRANSFERRED TO THE EMERGENCY DEPARTMENT FOR EVALUATION AND WAS DISCHARGED HOME THE SAME DAY. THE PATIENT HAS A DOCUMENTED HISTORY OF SEIZURES PRIOR TO IMPLANTATION. FOLLOW-UP INFORMATION INDICATED THE PATIENT EXPERIENCED AN ADDITIONAL SEIZURE AT HOME ON (B)(6) 2026. THE PATIENT'S NEUROLOGIST ADJUSTED THE PATIENT'S ANTISEIZURE MEDICATION AND REPORTEDLY DID NOT BELIEVE THE SEIZURES WERE RELATED TO VNS THERAPY. THE PATIENT RESUMED DAILY MAGNET THERAPY, RETURNED TO PART-TIME LANDSCAPING WORK, AND NO CHANGES WERE MADE TO THE VIVISTIM SYSTEM. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Convulsion/Seizure

  MAUDE report 25644397 ↗
• InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS IMPLANTED WITH THE VIVISTIM SYSTEM ON (B)(6) 2026. THE PATIENT HAS A PRE-EXISTING HISTORY OF EPILEPSY AND WAS TAKING ANTI-SEIZURE MEDICATION PRIOR TO IMPLANTATION. THE PATIENT'S PARTNER REPORTED THAT THE PATIENT EXPERIENCED EPISODES OF LIGHTHEADEDNESS TOWARD THE END OF THERAPY SESSIONS. ON (B)(6) 2026, IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED A SEIZURE ON (B)(6) 2026. IT WAS REPORTED THE SEIZURE WAS PROVOKED BY A VIRAL ILLNESS AND SKIN INFECTION, BOTH OF WHICH WERE TREATED AT HOME. BASED ON THE AVAILABLE INFORMATION, THE PATIENT WAS NOT RECEIVING DEVICE STIMULATION AT THE TIME OF THE SEIZURE. THE PATIENT HAS CONTINUED THERAPY, AND ADJUSTMENTS WERE MADE TO THE PATIENT'S SEIZURE MEDICATIONS TO ADDRESS THE REPORTED SYMPTOMS. REVIEW OF THE AVAILABLE INFORMATION DID NOT IDENTIFY A DEVICE MALFUNCTION, AND THE REPORTED EVENT DOES NOT APPEAR TO BE RELATED TO DEVICE PERFORMANCE OR THERAPY. ALTHOUGH A CAUSAL RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED EVENT HAS NOT BEEN ESTABLISHED, THIS EVENT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

  Patient problems: Convulsion/Seizure; Dizziness

  MAUDE report 25476884 ↗
• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS IMPLANTED ON (B)(6) 2025 AND BEGAN THERAPY PROTOCOL ON (B)(6) 2026. THE PATIENT LATER SUBSEQUENTLY REPORTED EXPERIENCING CHEST SHOCKING SENSATIONS WHILE THE DEVICE WAS NOT ACTIVELY DELIVERING STIMULATION. THE IMPLANTING PHYSICIAN REPLACED THE IPG ON (B)(6) 2026, AND THE ORIGINALLY IMPLANTED LEAD WAS NOT REPLACED. MOBIA MEDICAL PERSONNEL WERE NOT PRESENT DURING THE PROCEDURE. PATIENT DEVELOPED LEFT-SIDED WEAKNESS APPROXIMATELY TWO WEEKS AFTER THE REPLACEMENT PROCEDURE ON (B)(6) 2026, WAS IN HOSPITAL FOR TWO DAYS, AND DISCHARGED TO OUT-PATIENT REHAB; CT IMAGING WAS REPORTEDLY INCONCLUSIVE AS TO CAUSE. THE REPLACEMENT IPG WAS TURNED ON PER PHYSICIAN CLEARANCE ON (B)(6) 2026 TO SUPPORT AT HOME USE OF THE DEVICE. THE EXPLANTED IPG WAS RETURNED TO MOBIA MEDICAL FOR EVALUATION.

  Patient problems: Electric Shock

  MAUDE report 25310843 ↗
• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS IMPLANTED ON (B)(6) 2026. ON (B)(6) 2026, A REHABILITATION FACILITY REPORTED A SUSPECTED INFECTION AT THE IPG POCKET SITE AFTER THE PATIENT CANCELLED A SCHEDULED APPOINTMENT. THE PATIENT WAS SUBSEQUENTLY EVALUATED ON (B)(6) 2026 AND REMAINED ADMITTED OVER THE WEEKEND FOR OBSERVATION AND TREATMENT. IMPLANTING PHYSICIAN WAS NOTIFIED AND INITIATED INTRAVENOUS ANTIBIOTICS. CLINICAL ASSESSMENT INDICATED THAT THE INFECTION WAS SUPERFICIAL. THE PATIENT WAS DISCHARGED ON (B)(6) 2026 WITH A PRESCRIPTION FOR ORAL ANTIBIOTICS. THE PATIENT IS BEING FOLLOWED BY NURSE NAVIGATION AND INTERNAL TEAMS FOR ONGOING MONITORING.

  Patient problems: Medical device site infection

  MAUDE report 25061185 ↗
• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED SIGNIFICANT PAIN ASSOCIATED WITH SWALLOWING AND SPEAKING FOLLOWING DEVICE IMPLANTATION ON (B)(6) 2025. THE PATIENT DID NOT WANT THE DEVICE SETTINGS/STIMULATIONS ADJUSTED, PER THE PATIENTS REQUEST, THE DEVICE WAS EXPLANTED ON (B)(6) 2026.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 25022376 ↗
• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS IMPLANTED ON (B)(6) 2024. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SEIZURE APPROXIMATELY 10 MINUTES AFTER INITIATING A MAGNET SESSION ON (B)(6) 2025. A MAGNET SESSION, WHICH IS A PATIENT-INITIATED THERAPY PERIOD DURING WHICH THE VIVISTIM SYSTEM DELIVERS VAGUS NERVE STIMULATION (VNS) PAIRED WITH REHABILITATION EXERCISES. THE PATIENT WAS HOSPITALIZED OVERNIGHT, DURING WHICH AN EEG AND CT SCAN WERE PERFORMED. THE PATIENT WAS STARTED ON KEPPRA AND DISCHARGED THE FOLLOWING DAY. THE PATIENT HAD USED THE VIVISTIM SYSTEM FOR APPROXIMATELY 13 MONTHS, WITH NO REPORTED ISSUES.

  Patient problems: Convulsion/Seizure

  MAUDE report 24811085 ↗
• InjuryApr 7, 2026Device-Device Incompatibility; Patient Device Interaction Problem

  THE PATIENT WAS IMPLANTED ON (B)(6) 2025. DURING THE THIRD OCCUPATIONAL THERAPY SESSION, WHICH REPORTEDLY INVOLVED THE COMBINED USE OF EXTERNAL ELECTRICAL STIMULATION AT INCREASED SETTINGS AND THE VIVISTIM SYSTEM, THE PATIENT EXPERIENCED A LOSS OF CONSCIOUSNESS AND WAS TRANSPORTED TO THE EMERGENCY DEPARTMENT. THE PATIENT REPORTED EXPERIENCING AN INTENSE ELECTRICAL SENSATION ORIGINATING IN THE THUMB DURING THE COMBINED THERAPY.

  Patient problems: Electric Shock; Loss of consciousness

  MAUDE report 24811055 ↗
• MalfunctionApr 2, 2026No Apparent Adverse Event

  THE PATIENT WAS IMPLANTED ON (B)(6) 2026. DURING THE FIRST IN CLINIC THERAPY SESSION ON (B)(6) 2026, THE PATIENT'S IPG INDICATED THAT THE "DEVICE WAS IN ERI (EARLY REPLACEMENT INDICATOR)". LOG FILES AND MANUFACTURING RECORDS WERE REVIEWED FOR THE IPG S/N (B)(6). THE DEVICE IS FUNCTIONING AS EXPECTED AND ABLE TO PROVIDE THERAPY. THE DEVICE WAS RESET AND REPROGRAMMED ON (B)(6) 2026. THE ERI NOTIFICATION MESSAGE DID NOT TRIGGER AFTER THE RESET. WHILE THERE IS NO INJURY TO THE PATIENT OR MEDICAL/SURGICAL INTERVENTION REPORTED AT THIS TIME, IF THE MALFUNCTION WERE TO RECUR THE PATIENT COULD HAVE THEIR DEVICE ERRONEOUSLY REPLACED EARLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24772192 ↗
• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS IMPLANTED ON (B)(6) 2025. ON (B)(6) 2026, THE PATIENT EXPERIENCED NEUROLOGICAL SYMPTOMS INCLUDING SLURRED SPEECH, FACIAL DROOPING, COUGHING WITH STIMULATION, GENERALIZED WEAKNESS, IMPAIRED MOBILITY, AND MULTIPLE FALLS REQUIRING EMS TRANSPORT AND HOSPITAL ADMISSION. ER EVALUATION REPORTEDLY INCLUDED CT IMAGING AND LABS, WITH DEHYDRATION NOTED PER SURROGATE. THE PATIENT SELF-DISCHARGED. NO DEVICE MALFUNCTION WAS CONFIRMED AT THE TIME OF REPORT. DEVICE EVALUATION SHOWED NORMAL IMPEDANCE AND A NORMAL INCISION SITE. THE PATIENT REPORTED TRANSIENT COUGHING WITH STIMULATION BUT WAS UNSURE IF THIS WAS NEW. THE PATIENT AGREED TO TURN THE DEVICE OFF PENDING NEUROLOGICAL EVALUATION. MRI DOCUMENTATION WAS PROVIDED. FOLLOW-UP WITH A NEUROLOGIST IS SCHEDULED FOR ON (B)(6) 2026. DEVICE REMAINS OFF.

  Patient problems: Balance Problems; Cough; Fall; Muscle Weakness/Atrophy

  MAUDE report 24772191 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS IMPLANTED ON (B)(6) 2026 AND WAS EXPLANTED ON (B)(6) 2026 DUE TO AN INFECTION AT THE IPG IMPLANT SITE.

  Patient problems: Medical device site infection

  MAUDE report 24721412 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS IMPLANTED ON (B)(6) 2026. POSTOPERATIVELY, THE PATIENT DEVELOPED A HEMATOMA THAT REQUIRED ADDITIONAL SURGICAL INTERVENTION AND HOSPITALIZATION. THE SURGEON REPORTED NO SIGNS OF INFECTION CONTRIBUTING TO THE HEMATOMA. THE EVENT HAS SINCE RESOLVED, AND THE PATIENT IS CURRENTLY RECOVERING. THE VIVISTIM SYSTEM REMAINS IMPLANTED.

  Patient problems: Hematoma

  MAUDE report 24721382 ↗
• MalfunctionMar 19, 2026Failure to Deliver Shock/Stimulation

  PATIENT IS NOT ABLE TO ACTIVATE THE IPG DURING AT HOME THERAPY SESSIONS USING THE MAGNET. TROUBLESHOOTING STEPS WERE PERFORMED. THE PATIENT IS USING A MAGNET THAT WAS NOT PROVIDED BY MTI TO ACTIVATE THE DEVICE AT HOME. DEVICE WILL CONTINUE TO BE MONITORED BY MICROTRANSPONDER AND THE THERAPIST. IF NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24646434 ↗
• InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A REVISION PROCEDURE, DUE TO THE PATIENT REPORTING THAT THE DEVICE MOVES IN CHEST AND MAKE PATIENT UNCOMFORTABLE. NO DEVICES WILL BE RETURNED FOR EVALUATION, SINCE THIS WAS A REVISION ONLY.

  Patient problems: Discomfort

  MAUDE report 24407054 ↗
• InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS IMPLANTED ON (B)(6) 2024, PATIENT WAS EXPLANTED ON (B)(6) 2024 DUE TO INFECTION. NO ADDITIONAL INFORMATION WAS PROVIDED. DEVICE WAS NOT RETURNED TO MTI FOR EVALUATION.

  Patient problems: Medical device site infection

  MAUDE report 24406978 ↗
• InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THE PATIENT WAS IMPLANTED WITH THE VIVISTIM SYSTEM AT (B)(6). POSTOPERATIVELY, THE PATIENT DEVELOPED UNILATERAL VOCAL CORD PARALYSIS, RESULTING IN SPEECH DIFFICULTIES. THE PATIENT WAS EVALUATED BY ENT AND RECEIVED STEROID INJECTIONS WITH LIMITED IMPROVEMENT. A SUBSEQUENT FAT TRANSFER PROCEDURE TO THE VOCAL CORDS WAS PERFORMED, RESULTING IN PARTIAL IMPROVEMENT. THE PATIENT IS CURRENTLY PARTICIPATING IN SPEECH THERAPY. NO DEVICE MALFUNCTION HAS BEEN REPORTED.

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

  MAUDE report 24406716 ↗
• InjuryFeb 20, 2026Insufficient Device Problem Information

  PATIENT WAS IMPLANTED ON (B)(6) 2023. MTI WAS NOTIFIED THAT THE PATIENT WAS EXPLANTED ON (B)(6) 2024. NO ADDITIONAL INFORMATION WAS PROVIDED. DEVICE WAS NOT RETURNED TO MTI FOR EVALUATION.

  Patient problems: Insufficient Information

  MAUDE report 24406706 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  FOLLOWING IMPLANTATION SURGERY (B)(6) 2025, THE PATIENT DEVELOPED HOARSENESS. ENT EVALUATION DIAGNOSED LEFT VOCAL CORD PARESIS, DYSPHONIA, RECURRENT LARYNGEAL NERVE PALSY, AND VAGUS NERVE DISORDER. ON (B)(6) 2025, DEVICE CHARGE WAS REDUCED; VOICE REMAINED RASPY. ON (B)(6) 2026, THE PATIENT UNDERWENT LEFT VOCAL CORD INJECTION AND WAS KEPT OVERNIGHT DUE TO POST-ANESTHESIA DIFFICULTY. A SWALLOWING STUDY PERFORMED ON (B)(6) 2026 WAS REPORTED AS ENCOURAGING. SPEECH THERAPY IS PLANNED BUT HAD NOT STARTED AS OF (B)(6) 2026. AS OF 01/23/2026, THE PATIENT REPORTS NO IMPROVEMENT IN VOICE QUALITY. THE DEVICE REMAINS IMPLANTED. NO DEVICE MALFUNCTION HAS BEEN IDENTIFIED. INVESTIGATION IS ONGOING.

  Patient problems: Nerve Damage; Paresis; Voice alteration

  MAUDE report 24328355 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS IMPLANTED ON (B)(6) 2025. PATIENT REPORTED SWELLING AND BRUISING AT IPG IMPLANT SITE. PATIENT FOLLOWED UP WITH SURGEON AND PATIENT WAS EXPLANTED DUE TO INFECTION. MICROTRANSPONDER WAS NOT PRESENT FOR THE EXPLANT AND WAS NOT NOTIFIED UNTIL AFTER THE EXPLANT WAS COMPLETED.

  Patient problems: Medical device site infection

  MAUDE report 24324539 ↗
• InjuryJan 12, 2026Insufficient Device Problem Information

  THE PATIENT REPORTED EXPERIENCING A POST-OPERATIVE INFECTION THAT REQUIRED HOSPITALIZATION AND TREATMENT WITH IV ANTIBIOTICS.

  Patient problems: Unspecified Infection

  MAUDE report 24048869 ↗