TheraSphere Y90 Glass Microspheres 4.0 GBq 990700.SPERecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05060116920352), received between Jan 29, 2019 and Mar 27, 2025 — classified as 2 deaths, 5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED RADIOEMBOLIZATION-INDUCED LIVER DISEASE THAT WAS TREATED WITH MEDICATION. THE SUBJECT WAS ENROLLED INTO A CLINICAL STUDY ON (B)(6) 2025. PRE-TREATMENT MAA IMAGING DOCUMENTED A SIGNIFICANTLY HIGHER PERFUSION OF MAA ON TUMORS, DOSE TO PERFUSED LIVER 143 GY AND DOSE TO TOTAL NORMAL TISSUE WAS CURRENTLY UNAVAILABLE. LUNG SHUNT CALCULATION WAS 0 PERCENT. ON (B)(6) 2025, THE TREATMENT WITH THERASPHERE WAS PERFORMED TO THE LIVER WAS LOBAR (2 SEGMENTS IN THE PERFUSED VOLUME) THROUGH FEMORAL ARTERY AND 1 DOSE VIAL WAS ADMINISTERED; TOTAL ADMINISTERED ACTIVITY DOSE WAS REPORTED AS 1.613 GBQ. POST TREATMENT DOSIMETRY DOCUMENTED BETWEEN AVID UPTAKE IN TARGET LESION AND AVID UPTAKE IN ALL LESION?S DISTRIBUTION OF Y90 ON TUMORS. THE DOSE TO PERFUSED LIVER NORMAL TISSUE WAS 361 GY AND DOSE TO LIVER NORMAL TISSUE WAS 26 GY. LUNG DOSE CALCULATION WAS 0. ON (B)(6) 2025, COMBINATION THERAPY WITH 1500 MG DURVALUMAB FOLLOWED BY 300 MG OF TREMELIMUMAB WERE ADMINISTERED INTRAVENOUSLY. ON (B)(6) 2025, 39 DAYS POST THE THERASPHERE ADMINISTRATION SUBJECT NOTED WITH RADIOEMBOLIZATION-INDUCED LIVER DISEASE (REILD) AND WAS TREATED MEDICALLY WITH PREDNISOLONE (60 MG

  Patient problems: Anemia; Hyperbilirubinemia; Liver Damage/Dysfunction

  MAUDE report 21713288 ↗
• InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ROWAN CLINICAL STUDY. IT WAS REPORTED THAT THE SUBJECT EXPERIENCED VOMITING REQUIRING PRESCRIPTION MEDICATION. ON (B)(6) 2024, TREATMENT WITH THERASPHERE WAS PERFORMED. THERASPHERE WAS ADMINISTERED TO THE LIVER SELECTIVE THROUGH THE FEMORAL ARTERY. THREE DOSE VIALS WERE ADMINISTERED. TOTAL ADMINISTERED ACTIVITY WAS 4.29 GBQ. POST TREATMENT DOSIMETRY DOCUMENTED AVID UPTAKE IN TARGET LESION DISTRIBUTION OF Y-90 ON TUMORS. LUNG DOSE CALCULATION WAS 8.6 GY. ON (B)(6) 2024, ONE DAY POST THERASPHERE ADMINISTRATION, THE SUBJECT EXPERIENCED VOMITING. THE EVENT WAS TREATED WITH LEVOGASTROL (25MG/ DAILY). IT WAS FURTHER REPORTED THAT THE VOMITING RESOLVED ON (B)(6) 2024.

  Patient problems: Vomiting

  MAUDE report 20738721 ↗
• InjuryMar 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MFR REPORT NUMBER: 3002124543-2020-00006. (B)(4). SAE: LIVER ABSCESS (LIVER ABSCESS) CHOLECYSTITIS (CHOLECYSTITIS) THIS REPORT CONCERNS SUBJECT (B)(4), A MALE SUBJECT BORN IN (B)(6), WHO WAS ENROLLED IN STUDY (B)(6) ENTITLED "(B)(6) EVALUATING THERASPHERE® IN SUBJECTS WITH METASTATIC COLORECTAL CARCINOMA OF THE LIVER WHO HAS FAILED FIRST LINE CHEMOTHERAPY". THE SUBJECT WAS RANDOMIZED TO RECEIVE TREATMENT WITH THERASPHERE® FOR METASTATIC COLORECTAL CARCINOMA AND SECOND-LINE CHEMOTHERAPY. ON (B)(6) 2016, THE SUBJECT RECEIVED TREATMENT WITH TOTAL 1 VIAL OF THERASPHERE® IN THE RIGHT HEPATIC LOBE (LOT NO 1699117, EXPIRY DATE: 13 MAY 2016) AT A DOSE OF 110 GY. THE SUBJECT COMMENCED THE FIRST CYCLE OF STUDY SECOND LINE THERAPY FOLFOX REGIMEN ON (B)(6) 2016. THE FOLFOX REGIMEN WAS (OXALIPLATIN 148.75 MG IV, FOLINIC ACID 700 MG IV, FLUOROURACIL BOLUS 700 MG IV AND FLUOROURACIL 4200 MG IV CONTINUOUS INFUSION). ON (B)(6) 2016 THE SUBJECT WAS ALSO STARTED ON AVASTIN (BEVACIZUMAB) FROM THE SECOND CYCLE OF STUDY SECOND LINE THERAPY WITH TOTAL DOSE OF 325 MG IV. AVASTIN WAS NOT ADMINISTERED FROM THE SIXTH ((B)(6) 2016) THROUGH EIGHTH ((B)(6) 2016) CYCLE AND TENTH ((B)(6) 2016) THROUGH TWELFTH CYC

  Patient problems: Abscess

  MAUDE report 9881791 ↗
• InjuryOct 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AUTO-NOTIFICATION RECEIVED FROM DATATRAK SITE # 250011, SUBJECT NUMBER: B)(6) 2019. A SUBJECT HAS REPORTED A RELATED ADVERSE EVENT. PLEASE SEE THE FOLLOWING FOR MORE INFORMATION. SITE #: 250011. SUBJECT NUMBER: (B)(6). ADVERSE EVENT: RUPTURE OF ESOPHAGEAL VARICES. START DATE: (B)(6) 2011. RELATIONSHIP TO STUDY TREATMENT: PROBABLY RELATED. SERIOUS ADVERSE EVENT: YES. OUTCOME: RECOVERED/RESOLVED. PT: (B)(6) MALE DIAGNOSED WITH HCC: (B)(6) 2011 WITH PRESENCE OF PORTAL HYPERTENSION PVT LOCATION: INVASION OF (OR TUMOUR THROMBUS IN) SECOND ORDER BRANCHES OF THE PORTAL VEIN ETIOLOGIC ASSOCIATIONS WITH HCC: LIVER CIRRHOSIS, NON-ALCOHOLIC FATTY LIVER DISEASE, ALCOHOLISM. NO PRIOR SORAFENIB TREATMENT BEFORE THERASPHERE TREATMENT AND NO DISEASE SPECIFIC SURGERY, PATIENT HAS BILOBAR DISEASE, TARGET LESION: LIVER, RIGHT LOBE. TREATED WITH THERASPHERE (B)(6) 2011. ACTIVITY START OF TREATMENT: 4.11 GBQ. NO RESIDUALS REMAINING AFTER DELIVERY. LUNG SHUNT FRACTION 1.6%. NO CONCOMITANT MEDICATIONS. PATIENT PRESENTED WITH RUPTURE OF ESOPHAGEAL VARICES ON (B)(6) 2011. REPORTED AS A SAE DUE TO INITIAL OR PROLONGED HOSPITALIZATION. GRADE 3. END DATE (B)(6) 2011. PATIENT RECOVERED/RESOLVED. PATIENT PRESEN

  Patient problems: Death; Laceration(s) of Esophagus; Rupture

  MAUDE report 9166359 ↗
• InjuryJun 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INTERNAL MCN: (B)(4). IDE: (B)(4). SUBJECT: (B)(6). LAST SAE REPORT: 21 MAY 2019. SAE: HEPATIC FAILURE (HEPATIC FAILURE). THIS REPORT CONCERNS SUBJECT (B)(6), A FEMALE SUBJECT BORN IN (B)(6), 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) 2018, THE SUBJECT WAS RANDOMIZED TO RECEIVE TREATMENT WITH THERASPHERE® FOR METASTATIC COLORECTAL CARCINOMA AND SECOND-LINE CHEMOTHERAPY. ON (B)(6) 2018, THE SUBJECT RECEIVED FIRST CYCLE OF SECOND-LINE CHEMOTHERAPY, FOLFOX REGIMEN (OXALIPLATIN 154.77 MG INTRAVENOUS (IV), FOLINIC ACID 364.16 MG IV WHICH COMPLETED ON (B)(6) 2018 AND FLUOROURACIL 3641.6 MG IV WHICH COMPLETED ON (B)(6) 2018). ON (B)(6) 2018, THE SUBJECT RECEIVED TREATMENT WITH TOTAL 2 VIALS OF THERASPHERE®. THE RIGHT HEPATIC LOBE WAS TREATED WITH 1 VIAL (LOT NO 1899525, EXPIRY DATE: 30 NOV 2018) AT A DOSE OF 113.56 GY. ONE VIAL WAS ADMINISTERED IN THE LEFT HEPATIC LOBE (LOT NO 1899525, EXPIRY DATE: 30 NOV 2018) AT A DOSE OF 113.56 GY. ON (B)(6) 2019, THE SUBJECT RECEIVED MOST RECENT CYCLE (NINTH) OF SECOND-LINE CHEMOTHERAPY, F

  Patient problems: Liver Damage/Dysfunction

  MAUDE report 8662436 ↗
• DeathMay 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE IS FOLLOW-UP TO USADE REPORTS ORIGINALLY SUBMITTED IN 2014 (MANUFACTURE REPORT NUMBER: 3002124545-2014-00012). 2 THERASPHERE® VIALS WERE USED TO TREAT THIS PATIENT, IT CANNOT BE DETERMINED WHICH DEVICE CONTRIBUTED TO THIS FATAL EVENT. REFER TO MDR 3002124543-2019-00033 FOR THE OTHER DEVICE ASSOCIATED WITH THIS EVENT. MFR REPORT NUMBER: 3002124543-2019-00032. INTERNAL MCN: (B)(4). SUBJECT: (B)(6). LAST SAE REPORT: 15 APR 2019. SAE: RILD (RADIO-EMBOLIZATION INDUCED LIVER DISEASE) (RADIATION (B)(6)). THIS REPORT CONCERNS SUBJECT 0401-003, A FEMALE SUBJECT WHO WAS BORN IN 1948 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 06 FEB 2014, THE SUBJECT RECEIVED FIRST CYCLE OF SECOND-LINE CHEMOTHERAPY, FOLFIRI REGIMEN (IRINOTECAN, FOLINIC ACID AND FLUOROURACIL). ON (B)(6) 2014, THE SUBJECT RECEIVED TREATMENT WITH TOTAL 2 VIALS OF THERASPHERE®. THE RIGHT HEPATIC LOBE WAS TREATED AT A DOSE OF 118 GY (LOT NO. 4990036/18, EXPIRY DATE: 07 MAR 2014) AND AT A DOSE OF 136 GY IN THE LEFT HEPATIC LOBE (LOT NO. 4990031, EXPIRY DATE: 07 MAR 2014). ON

  Patient problems: Death; Hepatitis; Liver Damage/Dysfunction

  MAUDE report 8572849 ↗
• DeathJan 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LIMITED INFORMATION WAS REPORTED THAT A MALE PATIENT WAS PRESCRIBED 120 GY OF THERASPHERE TO TREAT PRIMARY HCC, WITH CHOLANGIOCARCINOMA IN RIGHT LOBE. THE LUNG SHUNT FRACTION WAS 18.5%. THE PATIENT RECEIVED 120.7 GY OF THERASPHERE TO THE LIVER ON (B)(6) 2018 AND DEVELOPED BILATERAL AIRSPACE DISEASE (SUSPECTED RADIATION PNEUMONITIS) 3 DAYS POST TREATMENT ON (B)(6) 2018. THE PHYSICIAN REPORTED THAT IT BECAME MORE INTERSTITIAL AND THEY TREATED THE PATIENT WITH STEROIDS ASSUMING THIS WAS RADIATION PNEUMONITIS. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED KIDNEY FAILURE. IT IS UNKNOWN AT THIS TIME IF RENAL INSUFFICIENCY WAS A PREEXISTING CONDITION. THE PATIENT DIED ON (B)(6) 2019, 13 DAYS AFTER THERASPHERE TREATMENT.

  Patient problems: Death; Liver Damage/Dysfunction; Renal Failure

  MAUDE report 8284499 ↗