Optune TFH9100 (REF TFH9100US)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07290107982214), received between Jun 17, 2024 and Jul 8, 2024 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 72-YEAR OLD FEMALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE GIO THERAPY ON (B)(6) 2024. IN A MEDICAL RECORD RECEIVED ON (B)(6) 2024, IT WAS NOTED THAT ON (B)(6) 2024, THE PATIENT ENDED OPTUNE GIO THERAPY. OPTUNE GIO THERAPY WAS DISCONTINUED DUE TO DISRUPTION OF DAILY ACTIVITIES DUE TO THE PRODUCT GIVING HIGH-TEMPERATURE ALARMS WHILE HIKING AND AT NIGHT, KEEPING HER AND HER PARTNER AWAKE. PATIENT REPORTED HER QUALITY OF LIFE HAD DIMINISHED SINCE STARTING OPTUNE GIO THERAPY. REPORTEDLY, PATIENT CANCELED A PLANNED TRIP AS PATIENT EXPERIENCED PASSIVE SUICIDAL IDEATION ASSOCIATED WITH OPTUNE GIO THERAPY. ON (B)(6) 2024, THE PRESCRIBING PHYSICIAN INFORMED NOVOCURE THAT THE PATIENT DID NOT REQUIRE HOSPITALIZATION OR TREATMENT FOR THE EVENT, AND WAS NOT EXPERIENCING DISEASE PROGRESSION AT THE TIME. ACCORDING TO THE PRESCRIBER, THE PATIENT HAD MADE A PASSIVE SUICIDAL IDEATION COMMENT TO HER SIGNIFICANT OTHER AT HOME. PER THE PRESCRIBER, THE PATIENT'S FRUSTRATION WITH THE DEVICE AND ITS LIMITATIONS (I.E., SHE COULDN'T HIKE WITH IT ON WITHOUT THE ELECTRODES OVERHEATING AND CAUSING THE MACHINE TO ALARM, FREQUENT WAKEUPS AT NIGHT DUE TO NOISE MADE BY THE DEVICE), CAUSED

  Patient problems: Suicidal Ideation

  MAUDE report 19688105 ↗
• InjuryJun 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 49-YEAR-OLD FEMALE WITH RECURRENT GLIOBLASTOMA (GBM) STARTED OPTUNE GIO THERAPY ON (B)(6) 2024. NOVOCURE WAS INFORMED ON (B)(6) 2024, THAT THE PATIENT EXPERIENCED HEADACHES AND NAUSEA SINCE STARTING OPTUNE GIO THERAPY. ON (B)(6) 2024, THE PATIENT'S CAREGIVER REPORTED THAT THE PATIENT WAS HOSPITALIZED AND TEMPORARILY DISCONTINUED OPTUNE GIO THERAPY SINCE (B)(6) 2024. NOVOCURE RECEIVED ADDITIONAL INFORMATION ON (B)(6) 2024, THAT THE FOUR DAYS THE PATIENT WAS ON OPTUNE GIO THERAPY, SHE WAS MISERABLE DUE TO HEADACHES THAT SUBSEQUENTLY LED TO BEING HOSPITALIZED. PER AN AVAILABLE MEDICAL RECORD, IT WAS DISCOVERED THE PATIENT HAD A HISTORY OF CHRONIC MIGRAINE HEADACHES WITHOUT AURA. THE PATIENT ENDED OPTUNE GIO THERAPY ON (B)(6) 2024. THE PRESCRIBING PHYSICIAN WAS CONTACTED FOR FURTHER DETAILS WITHOUT REPLY.

  Patient problems: Headache

  MAUDE report 19630982 ↗
• InjuryJun 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 66-YEAR-OLD FEMALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE GIO THERAPY ON (B)(6) 2024. DURING REVIEW OF AN AVAILABLE MEDICAL RECORD, IT WAS REPORTED ON (B)(6) 2024, THE PATIENT EXPERIENCED PERSISTENT WOUNDS ON THE SCALP IN RELATION TO OPTUNE GIO USAGE AND FROM PREVIOUS SURGERY. THE PHYSICIAN ADVISED ROTATING THE TRANSDUCER ARRAYS, AVOIDING THE AFFECTED AREAS, AND APPLYING TOPICAL CLOBETASOL CREAM AND CLINDAMYCIN GEL. NOVOCURE WAS INFORMED ON (B)(6) 2024, THAT WHEN THE PATIENT REMOVED THE TRANSDUCER ARRAYS A FEW DAYS PRIOR, THE SKIN ON THE SCALP WAS VERY THIN AND CRANIAL HARDWARE (METAL PLATE) HAD BECOME EXPOSED. OPTUNE GIO THERAPY WAS TEMPORARILY DISCONTINUED. ON (B)(6) 2024, THE PATIENT MET WITH A NEUROSURGEON THAT ADVISED ADDITIONAL SURGERY MIGHT BE NEEDED TO REMOVE THE CRANIAL HARDWARE. THE SPOUSE MENTIONED THAT POTENTIALLY, OPTUNE GIO THERAPY WOULD BE DISCONTINUED. THE PRESCRIBING PHYSICIAN WAS CONTACTED FOR FURTHER DETAILS WITHOUT REPLY.

  Patient problems: Wound Dehiscence

  MAUDE report 19621591 ↗
• InjuryJun 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 57-YEAR-OLD MALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) BEGAN OPTUNE GIO THERAPY ON (B)(6) 2017. NOVOCURE WAS INFORMED ON JANUARY 22, 2024, THAT THE PATIENT FELL AND SUSTAINED A CEREBRAL HEMORRHAGE THAT REQUIRED SURGERY. ON (B)(6) 2024, THE PATIENT REPORTED THAT HE HAD SURGERY ON AN UNSPECIFIED DATE DUE TO A WOUND COMPLICATION AT A PREVIOUS SURGICAL SITE. THE HEALTHCARE PROVIDER (HCP) ADVISED TO TEMPORARILY DISCONTINUE OPTUNE GIO THERAPY. THE PATIENT REPORTED ON (B)(6) 2024, THAT HE RESUMED OPTUNE GIO THERAPY. THE HCP REPORTED ON (B)(6) 2024, THE PATIENT FELL ON STAIRS, AND HAD A BRAIN BLEED THAT REQUIRED SURGERY, AND THE WOUND DID NOT HEAL CORRECTLY. THE CAUSE OF THE EVENT WAS THE PREVIOUS FALL AND SECONDARY BRAIN BLEED.

  Patient problems: Impaired Healing

  MAUDE report 19592052 ↗
• InjuryJun 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 54-YEAR-OLD MALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) BEGAN OPTUNE GIO THERAPY ON (B)(6) 2022. DURING REVIEW OF AN AVAILABLE PATIENT MEDICAL RECORD, ON (B)(6) 2024, THE PATIENT REPORTED THAT HE DEVELOPED A SUSPECTED PINCHED NERVE AND PAIN IN HIS SHOULDER, RELATED TO CARRYING THE OPTUNE GIO BATTERY PACK. THE PATIENT WAS IN PHYSICAL THERAPY AND TRANSITIONED TO USING A FANNY PACK FOR CARRYING THE DEVICE. ON (B)(6) 2024, THE PATIENT REPORTED THAT A FEW MONTHS PRIOR, DUE TO THE WEIGHT OF THE BAG AND WEARING IT CROSS-BODY, IT CAUSED A PINCHED NERVE WHICH RESULTED IN EIGHT WEEKS OF PHYSICAL THERAPY. REPORTEDLY, THE PATIENT WAS DOING MUCH BETTER AND APPRECIATED THE NEW BAG AND ABILITY TO WEAR IT ON HIS WAIST. THE PRESCRIBING PHYSICIAN WAS CONTACTED FOR FURTHER DETAILS WITHOUT REPLY.

  Patient problems: Arthralgia

  MAUDE report 19557779 ↗
• InjuryJun 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 66-YEAR-OLD MALE WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE GIO THERAPY ON (B)(6) 2022. NOVOCURE WAS INFORMED ON MAY 06, 2024, THAT THE PATIENT TEMPORARILY DISCONTINUED OPTUNE GIO THERAPY DUE TO SKIN IRRITATION IN THE LOCATION OF CRANIAL HARDWARE (SCREW). ON MAY 20, 2024, THE PATIENT REPORTED HE HAD RESUMED OPTUNE GIO THERAPY FOR ONE WEEK, ALTHOUGH HAD TO REPEATEDLY DISCONTINUE AS A "HOLE" DEVELOPED IN THE LOCATION OF CRANIAL HARDWARE AT THE PREVIOUS SURGICAL RESECTION SITE. IT WAS REPORTED THAT DURING A NEUROSURGEON EVALUATION ON (B)(6) 2024, THE SKIN IN THE REGION OF PREVIOUS SURGERY WAS VERY THIN AND DURING TRANSDUCER ARRAY CHANGES THE SKIN PULLED WHICH RESULTED IN A "HOLE" IN THE LOCATION OF CRANIAL HARDWARE. IN THE PROVIDED IMAGE THERE WAS EVIDENCE OF A WOUND DEHISCENCE WITH EXPOSED HARDWARE. THE PHYSICIAN ADVISED TO TEMPORARILY DISCONTINUE OPTUNE GIO THERAPY UNTIL FURTHER EVALUATION ON (B)(6) 2024. THE PRESCRIBING PHYSICIAN WAS CONTACTED FOR FURTHER DETAILS WITHOUT REPLY.

  Patient problems: Wound Dehiscence

  MAUDE report 19546837 ↗