TheraSphere Y90 Glass Microspheres 3.5 GBq 990700.SPERecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05060116920345), received between Oct 30, 2018 and Aug 28, 2025 — classified as 1 death, 5 injuries.

The most frequently reported specific device problem is “Malposition of Device” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED HEPATIC DYSFUNCTION POST THERASPHERE ADMINISTRATION. A THERASPHERE Y-90 (3.0 GBQ) DOSE VIAL AND A THERASPHERE Y-90 (3.5 GBQ) WAS SELECTED FOR USE IN THE RADIOEMBOLIZATION PROCEDURE. THE PATIENT WAS BEING TREATED FOR HEPATOCELLULAR CARCINOMA (HCC). THIS WAS A BILOBAR TREATMENT. THE WAS NOTED TO BE MULTIFOCAL WITH A TOTAL TUMOR VOLUME OF 29.3ML. THERE WAS NOTHING UNUSUAL OBSERVED DURING DEVICE PREPARATION OR THE THERASPHERE PROCEDURE. FOLLOWING THERASPHERE ADMINISTRATION, LIVER FUNCTION TESTS (LFTS) REVEALED THAT THE PATIENT WAS EXPERIENCING HEPATIC DYSFUNCTION. AS A RESULT, THE PATIENT WAS ADMINISTERED REILD PROPHYLAXIS (PREDNISOLONE 10 MG/D, UDC 500 MG BID, LWH). THERE WERE NO FURTHER PATIENT COMPLICATIONS.

  Patient problems: Liver Damage/Dysfunction

  MAUDE report 22917753 ↗
• DeathApr 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AUTO-NOTIFICATION RECEIVED FROM DATATRAK 12-MAR-2020 FOR A PATIENT ENROLLED ON THE (B)(6)STUDY PT: (B)(6) IS A (B)(6) OLD MALE PATIENT. WEIGHT: (B)(6) KG. MAIN COMORBIDITIES: ARTERIAL HYPERTENSION; ALCOHOL INTAKE HISTORY; TOBACCO INTAKE HISTORY. DIAGNOSED WITH HCC (B)(6) 2016. 2-4 LESIONS - RIGHT AND LEFT SEGMENTS. LOCATION OF INDEX LESION = VI. PVT PRESENT - YES (TUMOURAL) NO EXTRA HEPATIC DISEASE. PRIOR ANTI-CANCER THERAPY: LOCO REGIONAL LIVER TREATMENT(S) = 2. ABLATION: RFA, MICROWAVE OR CRYO. EVENT: ON (B)(6) 2019, PATIENT WAS ADMINISTERED 3.225 GBQ OF THERASPHERE IN THE RIGHT LIVER. ON (B)(6) 2019, PATIENT WAS ADMITTED TO THE HOSPITAL WITH HEPATITIS DECOMPENSATION WITH ASCITES AND JAUNDICE AT 1-MONTH POST-RADIO-EMBOLISATION. FURTHER, ASCITES AND PLEURAL EFFUSION APPARITION WITH REPEATED PARACENTESIS HAS BEEN REPORTED. ON (B)(6) 2019, RADIO-INDUCED LIVER DISEASE WAS REPORTED. SERIOUSNESS CRITERIA - LED TO A DEATH ON (B)(6) 2019. THE INVESTIGATOR HAS LISTED THE CAUSALITY PROBABLY RELATED TO THE ADMINISTRATION PROCEDURE AND TO THE DEVICE. SAE ASSESSED BY INVESTIGATOR: RELATED TO ADMINISTRATION PROCEDURE: PROBABLY. RELATED TO THERASPHERE DEVICE: PROBABLY. THIS EVENT IS PART OF A C

  Patient problems: Ascites; Jaundice; Liver Damage/Dysfunction; Pleural Effusion; Radiation Sickness Syndrome

  MAUDE report 9932767 ↗
• InjuryDec 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PHYSICIAN REPORTED: FOLLOWING THERASPHERE Y90 TREATMENT PATIENT EXPERIENCED A HEMO-PERITONEUM THAT REQUIRED A HEPATIC ARTERY EMBOLIZATION. THE FIRST 3 DAYS AFTER TREATMENT THEY FELT FINE BUT THEN GOT ADMITTED TO ANOTHER HOSPITAL WITH WEAKNESS. PATIENT IS STABLE NOW. ADDITIONAL INFORMATION RECEIVED: 11-DEC-2019. TREATMENT DATE: (B)(6) 2019. DATE OF EVENT: (B)(6) 2019. DOSE ADMINISTERED/LOCATION ETC: 3.58 GBQ "RADIATION SEGMENTECTOMY" RIGHT LOBE SUB-SEGMENT (DOMINANT MASS). ON WORK UP NUCLEAR SCAN 8% LUNG SHUNTING FRACTION.PATIENT UNDERWENT ANGIOGRAPHY BY OUTSIDE PROVIDERS ON 11/29/19 AND THEY PERFORMED GEL-FOAM EMBOLIZATION OF THE RIGHT HEPATIC ARTERY SUB-SEGMENT(S). THE PATIENT WAS TRANSFERRED TO UCI WHERE HE UNDERWENT ANOTHER RIGHT HEPATIC ARTERIAL GEL-FOAM EMBOLIZATION ON (B)(6) 2019. HGBS STABLE SINCE THEN. PATIENT WAS IN TO SEE PHYSICIAN (B)(6) 2019 AND IS DOING FINE WITH HGB STABLE. HEMORRAGE IS AN ANTICIPATED ADVERSE EVENT LISTED IN THE IFU/RISK MANAGEMENT DOCUMENTATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Weakness

  MAUDE report 9466039 ↗
• InjuryNov 20, 2019Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  REVIEW OF LITERATURE ARTICLE: THE VALUE OF YTTRIUM-90 PET/CT AFTER HEPATIC RADIOEMBOLIZATION:A PICTORIAL ESSAY. AUTHORS: AHMED A ALSULTAN ET AL. CASE #3: 90Y-PET/CT TO REVEAL INADVERTENT SELECTIVE DELIVERY OF 90Y-MICROSPHERES. A 68-YEAR-OLD MALE WITH A GRADE I NEUROENDOCRINE TUMOR OF THE SMALL BOWEL AND MULTIPLE LIVER METASTASES, FOR WHICH HE ALREADY RECEIVED FOUR CYCLES OF INTRAVENOUS 7400 MBQ LUTETIUM-177 (177LU)-DOTATATE, WAS REFERRED FOR RADIOEMBOLIZATION AFTER PROGRESSION OF THE LIVER METASTASES. THE PATIENT WAS PLANNED FOR WHOLE LIVER RADIOEMBOLIZATION WITH TWO INJECTION POSITIONS. A SUITABLE INJECTION POSITION WAS FOUND IN THE LHA AND 99MTC-MAA WAS ADMINISTERED. PROXIMALLY IN THE RIGHT HEPATIC ARTERY (RHA), TWO SMALL MEDIAL HEPATIC ARTERIES WERE IDENTIFIED, BUT COULD NOT BE CATHETERIZED SEPARATELY. THUS, AN INJECTION POSITION PROXIMAL TO THE SEGMENT IV BRANCHES WAS SELECTED AND 99MTC-MAA WAS ADMINISTERED. PLANAR IMAGING FOUND A NEGLIGIBLE LSF (4.3%), AND SPECT/CT SHOWED GOOD DISTRIBUTION OF MICROSPHERES THROUGHOUT THE LIVER, ALBEIT WITH A SLIGHTLY LOWER DEPOSITION OF ACTIVITY IN SEGMENT IV. AFTER WHICH, THE PATIENT PROCEEDED TO TREATMENT. GLASS 90Y-MICROSPHERES WERE INJECTED

  Patient problems: Abdominal Pain; Abscess; Fever; Radiation Overdose

  MAUDE report 9346062 ↗
• 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 3002124543-2019-00021 AND 3002124543-2019-00022 FOR THE OTHER DEVICE ASSOCIATED WITH THIS EVENT. MFR REPORT NUMBER: 3002124543-2019-00023. (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) 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 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

  Patient problems: Liver Damage/Dysfunction

  MAUDE report 8447900 ↗
• 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 3002124543-2018-00046 AND 3002124543-2018-00047 FOR THE OTHER DEVICE ASSOCIATED WITH THIS EVENT. MFR REPORT NUMBER: 3002124543-2018-00048. (B)(4). SUBJECT: (B)(6). LAST SAE REPORT: 19 OCT 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 BORN IN (B)(6), WHO WAS ENROLLED IN STUDY (B)(4) ENTITLED "A (B)(4) 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 SUB

  Patient problems: No Code Available

  MAUDE report 8018336 ↗