TheraSphere Y90 Glass Microspheres 10 GBq 990700.SPERecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05060116920314), received between Jun 29, 2017 and Dec 23, 2025 — classified as 1 death, 4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PRESCRIPTION MEDICATION WAS GIVEN TO TREAT ADVERSE EVENTS. THE SUBJECT WAS ENROLLED INTO A CLINICAL STUDY ON (B)(6) 2025. PRE-TREATMENT MACROAGGREGATED ALBUMIN (MAA) IMAGING DOCUMENTED A SIGNIFICANTLY HIGHER PERFUSION OF MAA ON TUMORS. LUNG SHUNT CALCULATION WAS 0.9%. ON (B)(6) 2025, THE TREATMENT WITH THERASPHERE WAS PERFORMED. THERASPHERE WAS ADMINISTERED TO THE LIVER WAS LOBAR (>2 SEGMENTS IN THE PERFUSED VOLUME) THROUGH FEMORAL ARTERY, AND ONE DOSE VIAL WAS ADMINISTERED; TOTAL ADMINISTERED ACTIVITY DOSE WAS 3.685 GBQ. POST TREATMENT DOSIMETRY DOCUMENTED BETWEEN AVID UPTAKE IN TARGET LESION DISTRIBUTION OF Y90 ON TUMORS. LUNG DOSE CALCULATION WAS 0.0. ON (B)(6) 2025, COMBINATION THERAPY WITH 1500 MG DURVALUMAB FOLLOWED BY 300 MG OF TREMELIMUMAB WERE ADMINISTERED INTRAVENOUSLY. ON (B)(6) 2025, 33 DAYS POST THERASPHERE ADMINISTRATION, THE SUBJECT WAS DIAGNOSED WITH ASTHENIA, DIFFICULTY IN MOVEMENT, AND SOMNOLENCE. NO ACTION WAS TAKEN TO TREAT THESE EVENTS. ON (B)(6) 2025, 38 DAYS POST THERASPHERE ADMINISTRATION, SUBJECT WAS NOTED WITH EPIGASTRIC PAIN, WHICH WAS MEDICALLY TREATED WITH PANTOPRAZOLE (40 MG/ORAL/DAILY FROM 25-JUL-2025 TO 22-AUG-2025). ON (B)(6) 20

  Patient problems: Abdominal Pain; Ambulation or Postural Difficulties; Ascites; Blood Protein Abnormal; Constipation; Depression; Heartburn/Indigestion; Hepatitis; Hyperbilirubinemia; Hypokalemia; Liver Damage/Dysfunction; Movement Disorder; Muscle Weakness/Atrophy; Sleep Dysfunction; Swelling/ Edema

  MAUDE report 23882155 ↗
• InjuryJan 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROACTIF CLINICAL STUDY: IT WAS REPORTED THAT THE PATIENT HAD ACUTE CHOLECYSTITIS. ADVANCED, MULTICOMPARTMENT DOSIMETRY WAS PERFORMED TO ASSESS TREATMENT DOSE. PRE-TREATMENT MACROAGGREGATED ALBUMIN (MAA) DOSIMETRY DOCUMENTED, DOSE TO TOTAL PERFUSED LIVER AS 346 GY. DOSE TO TOTAL PERFUSED TUMOR WAS 402 GY. ON (B)(6) 2023, THE SUBJECT WAS ENROLLED INTO THE PROACTIF STUDY AND THE TREATMENT WITH THERASPHERE WAS PERFORMED ON THE SAME DAY. TYPE OF THERASPHERE INFUSION WAS SELECTIVE FOR VIALS 1 AND 2. THE CATHETER WAS POSITIONED IN THE RIGHT POSTERIOR SECTOR (SEGMENTS VI/VII). 4.706 GBQ OF THERASPHERE WAS ADMINISTERED TO THE SELECTIVE LIVER THROUGH VIAL 1, AND 2.564 GBQ OF THERASPHERE WAS ADMINISTERED TO THE SELECTIVE LIVER THROUGH VIAL 2, AND TOTAL THERASPHERE ACTIVITY ADMINISTERED TO THE SELECTIVE LIVER WAS 7.27 GBQ. POST TREATMENT DOSIMETRY DOCUMENTED AN UPTAKE OF THE DELIVERED DOSE; DOSE TO TOTAL PERFUSED LIVER WAS NOT DETERMINED AND DOSE TO THE TOTAL PERFUSED TUMOR WAS 424 GY. ON (B)(6) 2023, ON THE SAME DAY OF INDEX PROCEDURE, THE SUBJECT WAS DIAGNOSED WITH ACUTE CHOLECYSTITIS. ON (B)(6) 2023, 03 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS HOSPITALIZED FOR FURTHER TREATMENT AND EVALU

  Patient problems: Inflammation

  MAUDE report 21103490 ↗
• InjuryJul 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 15 JUNE 2018, IT WAS REPORTED THAT A MALE PATIENT WAS TREATED WITH THERASPHERE ON (B)(6) 2018 (RIGHT LOBE TREATMENT) WITHOUT ISSUE. A SECOND THERASPHERE TREATMENT ON (B)(6) 2018 WAS ADMINISTERED TO THE PATIENT'S LEFT LOBE (1110 CC VOLUME, 133 GY, 10GBQ TREATMENT, 13% LUNG SHUNT FRACTION). THE PATIENT WAS ADMITTED TO THE HOSPITAL FOLLOWING THE SECOND TREATMENT (DATE UNKNOWN) FOR HEMATEMESIS AND COFFEE GROUND STOOLS. IT WAS CONFIRMED ON EGD THAT THE PATIENT HAD A GASTRIC ULCER. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2018. THE DURATION OF HOSPITALIZATION AND TREATMENT PROVIDED TO THE PATIENT WAS NOT REPORTED.

  Patient problems: Ulcer

  MAUDE report 7686823 ↗
• InjuryFeb 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MFR # 3002124543-2018-00008 . (RELATED TO MFR # 3002124543-2018-00014 AND 3002124543-2018-00015). THIS SUBJECT RECEIVED 3 THERASPHERE TREATMENTS, IT CANNOT BE DETERMINED WHICH DEVICE CONTRIBUTED TO THE SERIOUS INJURY. INTERNAL MCN: (B)(4) SUBJECT NUMBER: (B)(4) LAST SIGNIFICANT SAE REPORT: (B)(6) 2018 SAE: RADIATION INDUCED LIVER DAMAGE (RADIATION HEPATITIS) THIS REPORT CONCERNS SUBJECT (B)(4), A FEMALE SUBJECT BORN IN 1943, WHO WAS ENROLLED IN STUDY TS-102 ENTITLED "A PHASE III CLINICAL TRIAL EVALUATING THERASPHERE® IN SUBJECTS WITH METASTATIC COLORECTAL CARCINOMA OF THE LIVER WHO HAVE FAILED FIRST LINE CHEMOTHERAPY". ON (B)(6) 2015, THE SUBJECT STARTED TREATMENT WITH SECOND-LINE CHEMOTHERAPY FOR METASTATIC COLORECTAL CARCINOMA; FOLFIRI REGIMEN (IRINOTECAN, FLUOROURACIL AND FOLINIC ACID). ON (B)(6) 2016, THE SUBJECT RECEIVED SIXTH CYCLE OF SECOND-LINE CHEMOTHERAPY, FOLFIRI REGIMEN (IRINOTECAN 180 MG/M^2 IV, FLUOROURACIL 400 MG/M^2 IV AND 2400 MG/M^2 IV INFUSION AND FOLINIC ACID 350 MG IV). ON (B)(6) 2015, AS PER THE E-CRF THE SUBJECT RECEIVED THERASPHERE® 120 GY TO THE RIGHT AND LEFT HEPATIC LOBES. ON (B)(6) 2016, THE SUBJECT RECEIVED THERASPHERE® 100 GY TO THE RIGHT HEPATIC LOBE

  Patient problems: Death; Liver Damage/Dysfunction; Radiation Exposure, Unintended

  MAUDE report 7288263 ↗
• DeathJun 29, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS A FOLLOW-UP REPORT TO UPDATE, OUTCOME FOR THE EVENT OF ASCITES. MFR REPORT NUMBER: 3002124543-2017-00027. INTERNAL MCN: (B)(4). SUBJECT #: (B)(6). LAST SAE REPORTS: 01-AUG-2019. SAE: ASCITES (ASCITES); ACUTE RENAL FAILURE (ACUTE KIDNEY INJURY). ON (B)(6) 2017, THE SUBJECT DIED DUE TO PROGRESSION OF HCC. AT THE TIME OF DEATH, THE SUBJECT WAS NOT RECOVERED/NOT RESOLVED FROM THE EVENT OF ASCITES. NO FURTHER INFORMATION IS EXPECTED.

  Patient problems: Ascites; Death; Renal Failure

  MAUDE report 6676235 ↗