Optune Lua (NovoTTF-200T) TFT9200 (REF TFT9200US)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07290107983235), received between Nov 26, 2024 and Jul 27, 2026 — classified as 12 injuries.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  A 61-year-old female patient with Non-Small Cell Lung Cancer (NSCLC) began Optune Lua therapy on (b)(6) 2025. On July 01, 2026, Novocure received a medical record dated June 11, 2026, indicating that the patient experienced significant pruritus and skin irritation. The symptoms were managed with unspecified topical agents and oral hydroxyzine. The patient reported using Optune Lua therapy for 12 to 15 hours per day; however, due to worsening nocturnal pruritus, she adjusted her device usage schedule to minimize sleep disturbances. The patient was advised to moisturize the affected skin regularly and avoid sun exposure. Additionally, the healthcare provider recommended oral diphenhydramine at bedtime if the pruritus worsened. Attempts were made to contact the prescribing physician; however, no reply was received.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 50032841 ↗
• InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem

  A 60-YEAR-OLD MALE PATIENT WITH NON-SMALL CELL LUNG CANCER (NSCLC) - ADENOCARCINOMA STARTED OPTUNE LUA THERAPY ON (B)(6) 2026. ON (B)(6) 2026, A MEDICAL RECORD WAS RECEIVED BY NOVOCURE DOCUMENTING THAT, DURING AN ONCOLOGY FOLLOW UP APPOINTMENT ON (B)(6) 2026, THE PATIENT HAD DIFFICULTY TOLERATING OPTUNE LUA THERAPY, PARTICULARLY OVERNIGHT. THE PATIENT REPORTED SIGNIFICANT PRURITUS, HEAT, SWEATING, AND SEVERE DISCOMFORT WHILE SLEEPING WITH THE TRANSDUCER ARRAYS IN PLACE. THE PATIENT WAS ABLE TO TOLERATE DEVICE USE BETTER DURING DAYTIME HOURS. THE PATIENT ALSO REPORTED SENSATIONS OF EXPERIENCING CLAUSTROPHOBIA, PANIC, HYPERVENTILATION, AND INTERMITTENT SHORTNESS OF BREATH WHEN WEARING THE DEVICE. THE SPOUSE OBSERVED THAT THE PATIENT'S ANXIETY INCREASED DUE TO CONCERNS THAT THE INABILITY TO WEAR THE DEVICE COULD ADVERSELY AFFECT HIS PROGNOSIS. THE PHYSICIAN PRESCRIBED LORAZEPAM TO MANAGE THE PATIENT'S ANXIETY RELATED TO NIGHTTIME DEVICE INTOLERANCE. SEVERAL ATTEMPTS WERE MADE TO CONTACT THE PRESCRIBING PHYSICIAN WITH NO REPLY.

  Patient problems: Anxiety

  MAUDE report 25123251 ↗
• InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem

  A 76-YEAR-OLD MALE PATIENT WITH NON-SMALL CELL LUNG CANCER (NSCLC) BEGAN OPTUNE LUA THERAPY ON (B)(6), 2025. ON (B)(6), 2026, NOVOCURE WAS INFORMED THAT THE PATIENT HAD EXPERIENCED A RECURRENCE OF SKIN IRRITATION AND WAS TREATED WITH PREDNISONE. IT WAS ALSO REPORTED THAT THE PATIENT WAS EXPERIENCING EXCESSIVE SWEATING, WHICH LED TO THE ARRAYS PEELING OFF THE TORSO. ACCORDING TO THE AVAILABLE MEDICAL RECORD DATED FEBRUARY 06, 2026, THE PATIENT HAD PREVIOUSLY DISCONTINUED PREDNISONE 5MG IN (B)(6) 2026. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE PRESCRIBING PHYSICIAN; HOWEVER, NO REPLY WAS RECEIVED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 24994945 ↗
• InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 72-YEAR-OLD MALE PATIENT WITH NON-SMALL CELL LUNG CANCER (NSCLC) BEGAN OPTUNE LUA THERAPY ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT'S SPOUSE REPORTED TO NOVOCURE THAT THE PATIENT TEMPORARILY DISCONTINUED OPTUNE LUA THERAPY FROM JULY 10 TO (B)(6) 2025, DUE TO THE DEVELOPMENT OF A SEVERE BLISTERING RASH ON THE TORSO FROM THE ARRAYS. ADDITIONALLY, THE PATIENT EXPERIENCED A MILD RASH LOCALIZED TO THE ARMS AND NECK, ATTRIBUTED TO IMMUNOTHERAPY. THE HEALTHCARE PROVIDER (HCP) PRESCRIBED 2.5% HYDROCORTISONE CREAM; REPORTEDLY THE PATIENT HAD ALREADY BEEN USING A SKIN PREPARATION PRODUCT. AT THE TIME OF THE REPORT, THE RASH PERSISTED ON THE TORSO BUT HAD SIGNIFICANTLY IMPROVED, ALLOWING THE PATIENT TO RESUME OPTUNE LUA THERAPY. ON (B)(6) 2025, THE SPOUSE REPORTED THAT THE PATIENT HAD BEEN STRUGGLING WITH ONGOING SKIN IRRITATION SINCE STARTING OPTUNE LUA THERAPY, WITH A SEVERE RASH DEVELOPING AFTER THREE DAYS OF THERAPY INITIATION. THE PATIENT WAS SUBSEQUENTLY PRESCRIBED HYDROCORTISONE CREAM, DIPHENHYDRAMINE, AND STEROIDS. THE HCP SUSPECTED THE PATIENT DEVELOPED AN ALLERGIC REACTION TO THE ARRAYS. AS DESCRIBED IN THE REPORT, THE RASH WAS PAINFUL AND PRURITIC, WITH OPEN, PURULENT SORES LOC

  Patient problems: Hypersensitivity/Allergic reaction; Skin Inflammation/ Irritation

  MAUDE report 22882042 ↗
• InjuryAug 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 62-YEAR-OLD MALE PATIENT WITH NON-SMALL CELL LUNG CANCER (NSCLC) BEGAN OPTUNE LUA THERAPY ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT REPORTED EXPERIENCING MINOR SKIN IRRITATION LOCALIZED TO THE LEFT SIDE OF THE TORSO. SUBSEQUENTLY, DURING A HOME VISIT ON (B)(6) 2025, WITH THE PATIENT AND THE PATIENT'S CAREGIVERS, IT WAS NOTED THAT THE PATIENT HAD DEVELOPED A FEVER, SEVERE RASH AND WORSENING SKIN IRRITATION DURING THE PRIOR WEEK. THESE SYMPTOMS WERE SUSPECTED TO BE ASSOCIATED WITH THE INITIATION OF CHEMOTHERAPY ON (B)(6) 2025. THE PATIENT WAS PRESCRIBED A 10-DAY COURSE OF TRIMETHOPRIM/SULFAMETHOXAZOLE, ALONG WITH NYSTATIN AND A TOPICAL NUMBING CREAM. IT WAS ALSO REPORTED THAT THE TRANSDUCER ARRAYS WERE COMING OFF THE TORSO DURING EPISODES OF NIGHT SWEATS. ONE PHOTO WAS PROVIDED, DEPICTING THE PATIENT'S FRONT TORSO. THE IMAGE REVEALED ROUND, PAPULAR LIKE LESIONS WITH MODERATE SURROUNDING ERYTHEMA. TWO LESIONS WERE OBSERVED ON THE LEFT BREAST, ONE ON THE MID-LEFT ABDOMINAL QUADRANT, AND TWO LOCATED ADJACENT TO THE UMBILICUS. ADDITIONALLY, MILD SCATTERED ERYTHEMA WAS NOTED THROUGHOUT THE TORSO. ON (B)(6) 2025, NOVOCURE RECEIVED A MEDICAL RECORD DATED (B)(6) 2025, INDICATING THAT THE

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 22824998 ↗
• InjuryAug 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 75-YEAR-OLD MALE PATIENT WITH NON-SMALL CELL LUNG CANCER (NSCLC) BEGAN OPTUNE LUA THERAPY ON (B)(6) 2025. ON (B)(6) 2025, NOVOCURE RECEIVED A MEDICAL RECORD DATED (B)(6) 2025, INDICATING THAT THE PATIENT TEMPORARILY DISCONTINUED OPTUNE LUA THERAPY DUE TO PRURITIC MACULOPAPULAR RASH GRADE 3, DESCRIBED AS SIGNIFICANT ITCHY RASH ON THE CHEST AND UPPER BACK. THE PATIENT WAS INITIATED ON MEDIUM TO HIGH POTENCY TOPICAL STEROIDS. AT A FOLLOW UP APPOINTMENT ON (B)(6) 2025, IT WAS NOTED THAT OPTUNE LUA THERAPY HAD NOT YET RESUMED. HOWEVER, THE RASH IMPROVED, WITH GRADE 1 RASH REMAINING, LOCALIZED TO THE CENTRAL CHEST AROUND THE STERNUM AND UNDERNEATH THE RIGHT RIB CAGE. MILD ERYTHEMA WAS STILL PRESENT. THE PATIENT HAD BEEN PRESCRIBED TRIAMCINOLONE ACETONIDE 0.5% TOPICAL CREAM AND AMOXICILLIN 875 MG/POTASSIUM CLAVULANATE 125MG, TO BE TAKEN TWICE DAILY FOR FOURTEEN DAYS. ON (B)(6) 2025, THE PATIENT INFORMED NOVOCURE OF CONTINUED SKIN IRRITATION, INCLUDING OPEN AREAS ON THE TORSO. THE PATIENT REPORTED THAT HE HAD BEEN PRESCRIBED UNSPECIFIED ANTIBIOTICS AND OINTMENT. ON (B)(6) 2025, THE PRESCRIBING PHYSICIAN REPORTED THAT THE PATIENT TEMPORARILY DISCONTINUED OPTUNE LUA THERAPY ON (B)(6) 2025,

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 22824911 ↗
• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 62-YEAR-OLD MALE PATIENT WITH NON-SMALL CELL LUNG CANCER (NSCLC) STARTED OPTUNE LUA THERAPY ON (B)(6) 2025. DURING A REVIEW OF A MEDICAL RECORD RECEIVED BY NOVOCURE, ON (B)(6) 2025, IT WAS NOTED DURING AN ONCOLOGY AND HEMATOLOGY FOLLOW UP APPOINTMENT ON (B)(6) 2025, THAT THE PATIENT DEVELOPED A GRADE II PRURITIC RASH ON THE CHEST, ATTRIBUTED TO OPTUNE LUA THERAPY. THE PATIENT WAS PRESCRIBED HYDROXYZINE HCL 25MG TWICE DAILY AS NEEDED, AND TOPICAL CORTICOSTEROIDS. FOLLOWING THE INITIATION OF THE TREATMENT, THE PRURITUS ASSOCIATED WITH THE SKIN REACTION REPORTEDLY IMPROVED. THE PHYSICIAN RECOMMENDED CONTINUING WITH THE SKIN CARE REGIMEN. ATTEMPTS TO CONTACT THE PRESCRIBING PHYSICIAN FOR FURTHER DETAILS WERE MADE, BUT NO RESPONSE WAS RECEIVED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 22661609 ↗
• InjuryMay 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 75-YEAR-OLD MALE PATIENT WITH NON-SMALL CELL LUNG CANCER (NSCLC) STARTED OPTUNE LUA THERAPY ON (B)(6) 2025. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT EXPERIENCED SKIN IRRITATION, DESCRIBED AS BLISTERS AND BURNS, ATTRIBUTED TO THE USE OF THE ITE ARRAYS. LATER THAT SAME DAY, ADDITIONAL INFORMATION PROVIDED BY THE PATIENT'S DAUGHTER INDICATED THAT THE PATIENT HAD AN ALLERGIC REACTION AND WAS TREATED WITH ORAL DIPHENHYDRAMINE. WET TOWELS WERE ALSO APPLIED TO THE TORSO TO HELP ALLEVIATE THE BURNING SENSATION. IMAGES PROVIDED SHOWED DIFFUSE, ELEVATED HIVES ACCOMPANIED BY MILD TO MODERATE ERYTHEMA ON THE FRONT AND BACK TORSO, RIGHT THIGH, AND LEFT ARM. ON (B)(6) 2025, THE PATIENT'S DAUGHTER REPORTED AN IMPROVEMENT IN THE PATIENT'S CONDITION AND STATED THAT A HEALTHCARE PROVIDER (HCP) HAD PRESCRIBED ORAL STEROIDS. HOWEVER, ON (B)(6) 2025, NOVOCURE WAS NOTIFIED THAT THE PATIENT HAD DISCONTINUED OPTUNE LUA THERAPY DUE TO SKIN TOXICITY ISSUES. SEVERAL ATTEMPTS WERE MADE TO CONTACT THE PRESCRIBING PHYSICIAN WITH NO REPLY.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 21957992 ↗
• InjuryMay 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN 80-YEAR-OLD MALE PATIENT WITH NON-SMALL CELL LUNG CANCER (NSCLC) STARTED OPTUNE LUA THERAPY ON (B)(6) 2025. ON (B)(6) 2025, NOVOCURE WAS INFORMED THAT THE PATIENT HAD TEMPORARILY DISCONTINUED OPTUNE LUA THERAPY ON (B)(6) 2025, DUE TO THE DEVELOPMENT OF A RASH AFFECTING THE UPPER BODY, INCLUDING BOTH THE BACK AND FRONT. THE HEALTHCARE PROVIDER (HCP) PRESCRIBED UNSPECIFIED MEDICATIONS, INCLUDING AN ANTIBIOTIC, TO TREAT THE RASH. THE PROVIDED IMAGE DEMONSTRATED AREAS OF MILD ERYTHEMA ON THE RIGHT TORSO. ON (B)(6) 2025, THE PATIENT REPORTED THAT HE STILL EXPERIENCED ITCHING AND REMAINED OFF THERAPY. IN ADDITION, HE WAS EVALUATED BY A DERMATOLOGIST ON (B)(6) 2025, WHO DETERMINED THAT THE RASH WAS AN ALLERGIC REACTION TO THE ADHESIVE USED ON THE ARRAYS. ON (B)(6) 2025, IT WAS REPORTED THAT THE PRESCRIBING PHYSICIAN RECOMMENDED THE USE OF A SKIN BARRIER FILM AND TOPICAL CORTICOSTEROIDS. ADDITIONALLY, FOLLOWING THE DERMATOLOGIST'S CONSULTATION, ORAL CORTICOSTEROIDS WERE PRESCRIBED. ATTEMPTS TO CONTACT THE PRESCRIBING PHYSICIAN FOR FURTHER DETAILS WERE MADE, ALTHOUGH NO RESPONSE WAS RECEIVED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 21957965 ↗
• InjuryMar 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 75-YEAR-OLD FEMALE PATIENT WITH NON-SMALL CELL LUNG CANCER (NSCLC) STARTED OPTUNE LUA THERAPY ON (B)(6) 2025. ON MARCH 06, 2025, NOVOCURE WAS INFORMED THAT THE PATIENT EXPERIENCED A SKIN REACTION, DESCRIBED AS ITCHING ON HER BACK AFTER THE SECOND DAY OF WEARING THE TRANSDUCER ARRAYS. THE FRONT OF HER TORSO REPORTEDLY REMAINED UNAFFECTED. IT WAS NOTED THAT THE PATIENT HAD APPLIED A SKIN PREPARATION AND TOOK UNSPECIFIED ORAL ANTIHISTAMINES. THE PATIENT REMAINED ON OPTUNE LUA THERAPY. ATTEMPTS TO CONTACT THE PRESCRIBING PHYSICIAN FOR FURTHER DETAILS WERE MADE, BUT NO RESPONSE WAS RECEIVED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 21705214 ↗
• InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 76-YEAR-OLD MALE PATIENT WITH UNRESECTABLE BIPHASIC PLEURAL MESOTHELIOMA STARTED OPTUNE LUA THERAPY ON (B)(6) 2024. DURING REVIEW OF A MEDICAL RECORD RECEIVED BY NOVOCURE ON (B)(6) 2024, IT WAS NOTED ON (B)(6) 2024, THAT THE PATIENT EXPERIENCED A RASH DESCRIBED AS LARGE PAPULAR, VESICULAR ERYTHEMATOUS LESIONS THAT WERE TENDER AND BURNING WHERE ARRAYS WERE PLACED. THE RASH WAS LOCATED ON THE BACK AND CHEST AND NOT LIMITED TO THE AREA OF ARRAYS BUT ALSO IN OTHER REGIONS OF THE BODY. THE PHYSICIAN SUSPECTED IMMUNOTHERAPY (PEMBROLIZUMAB/ IPILIMUMAB) MIGHT CONTRIBUTE TO THE RASH. OPTUNE LUA THERAPY WAS TEMPORARILY DISCONTINUED. THE PATIENT WAS PRESCRIBED TRIAMCINOLONE OINTMENT, ORAL PREDNISOLONE AND HYDROXYZINE. ON (B)(6) 2024, THE RASH HAD MUCH IMPROVED AND THE PHYSICIAN INSTRUCTED THE PATIENT TO REINTRODUCE OPTUNE LUA THERAPY FOR 2-4 HOURS DAILY. THE RASH WAS STABLE ON (B)(6) 2024, AND THE PATIENT REMAINED ON OPTUNE LUA THERAPY FOUR HOURS DAILY. THE PRESCRIBING PHYSICIAN WAS CONTACTED FOR FURTHER DETAILS WITHOUT REPLY.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 20840974 ↗
• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN 85-YEAR-OLD MALE PATIENT WITH BIPHASIC PLEURAL MESOTHELIOMA STARTED OPTUNE LUA THERAPY ON (B)(6) 2022. DURING REVIEW OF THE PATIENT'S MEDICAL RECORDS, RECEIVED BY NOVOCURE ON JULY 30, 2024, IT WAS NOTED ON (B)(6) 2024, THE PATIENT DEVELOPED LOCALIZED SKIN IRRITATION, CHARACTERIZED BY ITCHING AND A RASH ORIGINATING FROM HAIR FOLLICLES, SECONDARY TO OPTUNE LUA THERAPY. THE PATIENT WAS SUBSEQUENTLY EVALUATED BY A DERMATOLOGIST AND TREATED WITH HYDROXYZINE AND DIPHENHYDRAMINE TO ALLEVIATE THE ITCHING. ON NOVEMBER 21, 2024, THE PATIENT INFORMED NOVOCURE THAT HE HAS BEEN SUFFERING FROM ITCHING FOR TWO YEARS, WHICH MADE IT DIFFICULT FOR HIM TO FALL ASLEEP. REPORTEDLY, THE PATIENT TRIED MANY OVER-THE-COUNTER OINTMENTS, WAS SEEN BY A DERMATOLOGIST AND WAS CHANGING THE ARRAYS DAILY. THE PRESCRIBING PHYSICIAN WAS CONTACTED FOR FURTHER DETAILS WITHOUT REPLY.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 20783796 ↗