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

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07290107983129), received between Jan 26, 2026 and Apr 17, 2026 — classified as 3 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. How this data works · Data updated Oct 13, 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.

• InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem

  A 76-YEAR-OLD FEMALE PATIENT WITH NON-SMALL CELL LUNG CANCER (NSCLC) BEGAN OPTUNE LUA THERAPY ON (B)(6) 2025. ON (B)(6) 2026, THE PATIENT REPORTED TO NOVOCURE THAT SHE HAD TEMPORARILY DISCONTINUED OPTUNE LUA THERAPY DUE TO SEVERE ITCHING, WHICH WAS DESCRIBED AS INTENSE ENOUGH TO DISRUPT HER SLEEP. THE PATIENT REPORTED USING A SKIN PREPARATION PRODUCT AND TAKING UP TO 2000 MG PER DAY OF UNSPECIFIED ANTI-ITCHING MEDICATION. ON (B)(6) 2026, THE PATIENT CLARIFIED THAT SHE HAD BEEN PRESCRIBED ORAL HYDROXYZINE. THE PATIENT'S PRESCRIBING PHYSICIAN WAS CONTACTED FOR ADDITIONAL INFORMATION AND RESPONDED ON (B)(6) 2026, STATING THAT THIS EVENT HAD NOT BEEN TREATED IN THEIR OFFICE AND THAT THE PATIENT CONTINUED OPTUNE LUA THERAPY. THE PHYSICIAN FURTHER INDICATED THAT THE PRESCRIPTION FOR HYDROXYZINE WAS LIKELY ISSUED BY ANOTHER HEALTHCARE PROVIDER.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 24911724 ↗
• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  A 79-YEAR-OLD MALE WITH NON-SMALL CELL LUNG CANCER (NSCLC) BEGAN OPTUNE LUA THERAPY ON (B)(6) 2026. ON (B)(6) 2026, THE PATIENT'S SPOUSE INFORMED NOVOCURE THAT THE PATIENT EXPERIENCED WEAKNESS ON THE LEFT SIDE INCLUDING THE ARM, HAND, AND LEG IMMEDIATELY FOLLOWING THE REMOVAL OF THE TRANSDUCER ARRAYS FROM THE TORSO. ON (B)(6) 2026, THE SPOUSE DESCRIBED THE PATIENT'S SYMPTOMS AS IT APPEARED THAT HE HAD NO CONTROL OF HIS MOVEMENTS, WHICH LASTED APPROXIMATELY 30 MINUTES. THE PATIENT WAS TRANSPORTED TO THE EMERGENCY ROOM (ER) WHERE HE WAS MONITORED OVERNIGHT. DURING THE HOSPITALIZATION, THE PATIENT UNDERWENT DIAGNOSTIC TESTING INCLUDING A MAGNETIC RESONANCE IMAGING (MRI) SCAN, WHICH SHOWED NO EVIDENCE OF A CEREBROVASCULAR ACCIDENT OR OTHER ACUTE FINDINGS. THE ER PHYSICIAN INDICATED THAT THE EVENT MAY HAVE BEEN RELATED TO DEVICE USE. ON (B)(6) 2026, THE PRESCRIBING PHYSICIAN REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO INVOLUNTARY ARM MOVEMENTS AND TEMPORARILY DISCONTINUED OPTUNE LUA THERAPY. AT THAT TIME, THE PATIENT DID NOT EXPERIENCE DISEASE PROGRESSION. THE PHYSICIAN ASSESSED THAT THE EVENT WAS LIKELY CAUSED BY OPTUNE LUA THERAPY.

  Patient problems: Dyskinesia

  MAUDE report 24636750 ↗
• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  AN 83-YEAR-OLD FEMALE WITH MALIGNANT PLEURAL MESOTHELIOMA (MPM) INITIATED OPTUNE LUA THERAPY ON (B)(6) 2025. ON (B)(6) 2025, NOVOCURE RECEIVED A MEDICAL RECORD INDICATING THAT DURING AN APPOINTMENT WITH RADIATION ONCOLOGY ON (B)(6) 2025, THE PATIENT REPORTED SIGNIFICANT SKIN IRRITATION, INCREASED SENSITIVITY, AND A SENSATION OF SKIN "RIPPING" ATTRIBUTED TO THE USE OF THE OPTUNE LUA DEVICE. THE PATIENT WAS PRESCRIBED CLOBETASOL OINTMENT, WHICH CAUSED A BURNING SENSATION UPON APPLICATION. THE PATIENT TEMPORARILY DISCONTINUED OPTUNE LUA THERAPY. DURING AN APPOINTMENT ON (B)(6) 2025, IT WAS DOCUMENTED THAT THE PATIENT HAD A HISTORY OF DELAYED WOUND HEALING ON THE LEFT CHEST WALL, SECONDARY TO OPTUNE LUA USE. THE PATIENT HAD APPLIED CLOBETASOL, MOMETASONE, AND SILVER SULFADIAZINE OINTMENTS WITHOUT CLINICAL IMPROVEMENT. THE PATIENT HAD DISCONTINUED OPTUNE LUA OVER ONE MONTH PRIOR DUE TO GRADE 2 DERMATITIS. OVER THE TWO WEEKS PRECEDING THE APPOINTMENT, THE PATIENT EXPERIENCED PROGRESSIVE ERYTHEMA, SWELLING, AND PAIN INVOLVING THE LEFT BREAST, AXILLA, AND CHEST WALL. CLINICAL EXAMINATION REVEALED MODERATE ERYTHEMA, WARMTH, TENDERNESS, AND SKIN INDURATION, MOST PRONOUNCED IN THE LEFT INFERI

  Patient problems: Cellulitis; Ulcer

  MAUDE report 24177929 ↗