TheraSphere Y90 Glass Microspheres 5 GBq 990700.SPERecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05060116920291), received between Sep 18, 2017 and Feb 5, 2025 — classified as 1 death, 7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA CLINICAL STUDY THAT THE SUBJECT EXPERIENCED THROMBOSIS REQUIRING MEDICATION. THE SUBJECT WAS ENROLLED INTO THE STUDY ON (B)(6) 2024. PRE-TREATMENT MAA (MACROAGGREGATED ALBUMIN) IMAGING DOCUMENTED A SIGNIFICANTLY HIGHER PERFUSION OF MAA ON TUMORS. LUNG SHUNT CALCULATION WAS 5.8%. ON (B)(6) 2024, THE FIRST TREATMENT WITH THERASPHERE WAS PERFORMED. THERASPHERE ADMINISTERED TO THE LIVER WAS MULTIPLE SELECTIVE THROUGH THE RADIAL ARTERY. TWO DOSE VIALS WERE ADMINISTERED. TOTAL ADMINISTERED ACTIVITY DOSE WAS 2.35 GBQ. POST TREATMENT DOSIMETRY DOCUMENTED BETWEEN RANDOM ACTIVITY DISTRIBUTION AND AVID UPTAKE IN TARGET LESION DISTRIBUTION OF Y90 ON TUMORS. LUNG DOSE CALCULATION WAS 7.6%. ON (B)(6) 2024, THE SECOND TREATMENT WITH THERASPHERE WAS PERFORMED. ONE DOSE VIAL WAS ADMINISTERED. -PRE-TREATMENT MAA IMAGING DOCUMENTED AN AVID UPTAKE IN TARGET LESION, DOSE TO PERFUSED LIVER WAS 400 GY. LUNG SHUNT CALCULATION WAS 9.89%. THERASPHERE ADMINISTERED TO THE LIVER WAS MULTIPLE SELECTIVE THROUGH THE RADIAL ARTERY. TOTAL ADMINISTERED ACTIVITY DOSE WAS 2.21 GBQ. POST TREATMENT DOSIMETRY DOCUMENTED BETWEEN RANDOM ACTIVITY DISTRIBUTION AND AVID UPTAKE IN TARGET LESION DISTRIBUTION

  Patient problems: Hyperbilirubinemia; Liver Damage/Dysfunction; Low White Blood Cell Count; Thrombosis/Thrombus

  MAUDE report 21318090 ↗
• InjuryJan 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS ENROLLED IN THE IMMUWHY CLINICAL STUDY WITH PATIENT IDENTIFIER (B)(6). IT WAS REPORTED THE PATIENT HAD PROLONGED HOSPITALIZATION DUE TO LOW PLATELET COUNTS. ON (B)(6) 2021, THE PATIENT WAS TREATED WITH THERASPHERE 103 GY ALONG WITH STUDY MEDICATION DURVALUMAB AND TREMELIMUMAB. ON (B)(6) 2021, THE PATIENT WAS DIAGNOSED WITH THROMBOCYTOPENIA/LOW PLATELET COUNTS (GRADE 4) AND HOSPITALIZATION WAS PROLONGED FOR FURTHER OBSERVATION. ON (B)(6) 2021, THE SYMPTOMS WERE RESOLVING, AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL.

  Patient problems: Thrombocytopenia

  MAUDE report 18575937 ↗
• InjuryNov 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SUBJECT WAS ENROLLED IN THE IMMUWHY INVESTIGATOR-INITIATED STUDY (IIS) WITH PATIENT IDENTIFIER (B)(6). IT WAS REPORTED THAT THE SUBJECT EXPERIENCED ESOPHAGEAL VARICES HEMORRHAGE. THE SUBJECT WAS HOSPITALIZED, AND INTERVENTION WAS PERFORMED AS A RESULT. ON (B)(6) 2023, THE SUBJECT WAS TREATED WITH 5 GBQ OF THERASPHERE Y-90 GLASS MICROSPHERES. ON (B)(6) 2023, THE SUBJECT WAS ADMITTED TO HOSPITAL FOR ESOPHAGEAL VARICES HEMORRHAGE WITH SECONDARY SYMPTOM HEMATEMESIS. TO TREAT THE EVENT, RUBBER BAND LIGATION WAS PLACED. THE EVENT WAS CONSIDERED TO BE ONGOING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Vomiting

  MAUDE report 18163970 ↗
• InjuryOct 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AUTO-NOTIFICATION RECEIVED FROM (B)(6) 02-OCT-2019 FOR A PATIENT ENROLLED ON CLINICAL TRIAL (B)(6), TARGET SUBJECT NUMBER: (B)(6). SUBJECT NUMBER: (B)(6). ADVERSE EVENT: SURINFECTION OF HEPATIC NECROSIS. START DATE: (B)(6) 2017. RELATIONSHIP TO STUDY TREATMENT: RELATED. SERIOUS ADVERSE EVENT? YES. OUTCOME: RECOVERED/RESOLVED. END DATE: (B)(6) 2017. PT (B)(6) IS A (B)(6) YEAR-OLD MALE DIAGNOSED WITH HCC (B)(6) 2016. NO PRESENCE OF PORTAL HYPERTENSION. ETIOLOGIC ASSOCIATIONS: LIVER CIRRHOSIS. ALCOHOL NO PRIOR SORAFENIB TREATMENT BEFORE THERASPHERE TREATMENT. BASELINE BCLC STAGE: B. NO ASCITES. UNILOBAR DISEASE. TARGET LESION: LIVER, RIGHT LOBE. THERASPHERE TREATMENT: (B)(6) 2017. ACTIVITY RECORDED AT START OF INFUSION 5.2 GBQ, NO RESIDUALS REMAINING IN DELIVERY SET LUNG SHUNT FRACTION 3%. TOTAL PERFUSED LIVER 71.2%. EVENTS: ASTHENIA - START UNKNOWN - (B)(6) 2017; TOXICITY GRADE 2. PATIENT PRESENTED WITH SURINFECTION OF HEPATIC NECROSIS ON (B)(6) 2017. TOXICITY GRADE 4. ACTION TAKEN: SCAN 23 (B)(6) 2017 / ENDOSCOPY (B)(6) 2017 (GASTRITIS DIAGNOSED) / ECHOGRAPHY (B)(6) 2017 (NORMAL) / CBEU (B)(6) 2017 (NEGATIVE). THE EVENTS WERE NOT REPORTED TO BTG IN 2017. ASTHENA (WEAKNESS) AND SURIN

  Patient problems: Necrosis; Unspecified Infection; Weakness

  MAUDE report 9151149 ↗
• InjuryMar 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  3 THERASPHERE® VIALS WERE USED TO TREAT THIS PATIENT, IT CANNOT BE DETERMINED WHICH DEVICE CONTRIBUTED TO THIS CLINICALLY SIGNIFICANT EVENT. REFER TO MDR 3002124543-2019-00022 AND 3002124543-2019-00023 FOR THE OTHER DEVICE ASSOCIATED WITH THIS EVENT. (B)(4). SUBJECT: (B)(6). LAST SAE REPORT: 14 MAR 2019. SAE: LIVER FAILURE (HEPATIC FAILURE). THIS REPORT CONCERNS SUBJECT (B)(6), A MALE SUBJECT BORN IN (B)(6), WHO WAS ENROLLED IN STUDY (B)(6)". 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, FOLFIRI REGIMEN (IRINOTECAN 337 MG INTRAVENOUS (IV), FOLINIC ACID 749 MG IV AND FLUOROURACIL 749 MG AND 4495 MG IV WHICH COMPLETED ON (B)(6) 2019). ON (B)(6) 2018, THE SUBJECT RECEIVED TREATMENT WITH TOTAL 3 VIALS OF THERASPHERE®. THE RIGHT HEPATIC LOBE WAS TREATED WITH TWO VIALS (LOT NO 1899055, EXPIRY DATE: 23 FEB 2018 AND 1899048, EXPIRY DATE: 16 FEB 2018) AT A DOSE OF 119.89 GY AND 110.91 GY (SEGMENT 8 ONLY). ONE VIAL WAS ADMINISTERED IN THE LEFT HEPATIC LOBE (LOT NO 1899048, EXPIRY DATE: 16 FEB 2018) AT A DOSE OF 115

  Patient problems: Liver Damage/Dysfunction

  MAUDE report 8447841 ↗
• InjuryOct 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE HAS BEEN ALSO REPORTED AS A USADE ASSOCIATED WITH THE IDE. 3 THERASPHERE® VIALS WERE USED TO TREAT THIS PATIENT, IT CANNOT BE DETERMINED WHICH DEVICE CONTRIBUTED TO THIS CLINICALLY SIGNIFICANT EVENT. REFER TO MDR 3002124543-2018-00047 AND 3002124543-2018-00048 FOR THE OTHER DEVICE ASSOCIATED WITH THIS EVENT. (B)(4). IDE: (B)(4). SUBJECT: (B)(6). LAST SAE REPORT: (B)(6) 2018. SAE: SYMPTOMATIC NON-CIRRHOTIC PORTAL HYPERTENSION DEFINITELY RELATED TO SIRT (THERASPHERE) (NON-CIRRHOTIC PORTAL HYPERTENSION) THIS REPORT CONCERNS SUBJECT (B)(6), A MALE SUBJECT (B)(6), WHO WAS ENROLLED IN STUDY (B)(6) 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, FOLFIRI REGIMEN (IRINOTECAN 337 MG, FOLINIC ACID 749 MG AND FLUOROURACIL 749 MG AND 4495 MG INTRAVENOUS (IV) WHICH COMPLETED ON (B)(6) 2018). ON (B)(6) 2018, THE SUBJECT RECEIVED TREATMENT WITH TOTAL

  Patient problems: No Code Available

  MAUDE report 8018331 ↗
• DeathFeb 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS A FOLLOW-UP REPORT TO UPDATE MEDICAL HISTORY, BILIRUBIN LEVELS, SUBJECT'S COURSE OF EVENT, EVENT OUTCOME, SERIOUSNESS AND SEVERITY TO DEATH, THAT THE EVENT WAS POSSIBLY RELATED TO STUDY PROCEDURE AND WAS RELATED TO DISEASE UNDER STUDY - LIVER METASTASES. MFR REPORT NUMBER: (B)(4). THE 3 THERASPHERE VIALS WERE USED TO TREAT THIS PATIENT, IT CANNOT BE DETERMINED WHICH DEVICE CONTRIBUTED TO THE SERIOUS INJURY. REFER TO MDR 3002124543-2018-00009 AND 3002124543-2018-00016 FOR THE OTHER DEVICES ASSOCIATED WITH THIS EVENT. INTERNAL MCN: (B)(4). SUBJECT# (B)(4). LAST SAE REPORT: (B)(4) 2018. SAE: WORSENING BILIRUBIN LEVELS (BLOOD BILIRUBIN INCREASED). THE SUBJECT'S MEDICAL HISTORY INCLUDED CANCER OF SIGMOID COLON WITH METASTASES TO LIVER. ON (B)(6) 2018, BILIRUBIN LEVEL DECREASED TO 12 MG/DL; ON (B)(6) 2018, BILIRUBIN LEVEL WAS 11.2 MG/DL. ON (B)(6) 2018, BILIRUBIN LEVEL INCREASED TO 13.1 MG/DL. ON (B)(6) 2018, BILIRUBIN LEVEL WAS 12 MG/DL AND THE PLEUREX DRAIN BEGAN TO LEAK. THE SUBJECT'S HAD 10/10 PAIN ON SCALE AND THERE WAS NO INFECTION. THE DRAIN WAS REPLACED WITH A NEW ONE ON (B)(6) 2018 WITHOUT COMPLICATIONS. THE SUBJECT COMPLETED END OF STUDY AND WAS ON LONG-TERM FOLLOW-UP U

  Patient problems: Death; Hyperbilirubinemia

  MAUDE report 7298661 ↗
• InjurySep 18, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS A FOLLOW-UP REPORT TO UPDATE SAE VERBATIM TERM TO NON CARDIAC INTERMITTENT, SEVERE CENTRAL CHEST PAIN. MFR# 3002124543-2017-00043. IDE # 100324. INTERNAL MCN: 2016M5000129. SUBJECT NUMBER: 0914-003. LAST SIGNIFICANT SAE REPORT: 02 MAR 2018. SAE: NON CARDIAC INTERMITTENT, SEVERE CENTRAL CHEST PAIN (MEDDRA PT: NON-CARDIAC CHEST PAIN).

  Patient problems: Chest Tightness/Pressure

  MAUDE report 6871619 ↗