TheraSphere Y90 Glass Microspheres 5.5 GBq 990700.SPERecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05060116920376), received between Feb 22, 2018 and Jan 8, 2025 — classified as 1 death, 2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• 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 21103488 ↗
• DeathMar 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AUTO-NOTIFICATION RECEIVED FROM DATATRAK 13-FEB-2020 FOR A PATIENT ENROLLED ON THE (B)(6) STUDY AS FOLLOWS: SITE NUMBER (SITEID): (B)(4). UNIQUE PATIENT ID: (B)(6). SAE NUMBER: 1 DIAGNOSTIC TERM TO DESCRIBE PRIMARY SAE: EDEMATO-ASCITES DECOMPENSATION. SERIOUSNESS CRITERIA: LED TO A DEATH. START DATE: (B)(6) 2019. SAE OUTCOME: FATAL. SEVERITY (CTCAE V5.0 GRADE): (SAESEV): GRADE 4. CAUSALITY RELATED TO ADMINISTRATION PROCEDURE (SAECAUSDEV): PROBABLY. CAUSALITY RELATED TO THERASPHERE DEVICE (SAECAUSMAA): PROBABLY. INCIDENT: ON (B)(6) 2019 (1ST OCCURRENCE OF ASCITES) AT THE FIRST FOLLOW-UP VISIT POST TREATMENT THE PATIENT PRESENTED, GRADE 3 ASCITES, JAUNDICE WITH BILIRUBIN AT 76 UMOL/L (GRADE 3), ECOG 2. A PARACENTESIS WAS PERFORMED (3L), ASCITES NON INFECTED: LIVER FUNCTION DETERIORATION POST SIR, WITH ASCITES ON (B)(6) 2019 (2ND OCCURRENCE OF ASCITES) THE PATIENT WAS HOSPITALISED FOR PARACENTESIS, EVACUATION OF 4 L OF ASCITES WITH NO INFECTION. WEIGHT LOSS OF -15KG WITHIN 18DAYS - ANOREXIA, NO ASTHENIA. ON (B)(6) 2019 THE PATIENT WAS HOSPITALISED - (UNKNOWN ADVERSE EVENT), NO ASCITES SUBTRACTION, PROTHROMBIN RATIO (PR) 31%, ON (B)(6) 2019 ASTHENIA, DIARRHOEA, CONFUSION, PRESCRIPTION

  Patient problems: Ascites; Death; Diarrhea; Encephalopathy; Fatigue; Hyperbilirubinemia; Liver Damage/Dysfunction; Test Result; Weight Changes

  MAUDE report 9811688 ↗
• InjuryFeb 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MFR # 3002124543-2018-00013. (B)(4). (B)(6). LAST SAE REPORT: 01 FEB 2018. SAE: GASTRIC PERFORATION (GASTRIC PERFORATION) . THIS REPORT CONCERNS (B)(6), A FEMALE SUBJECT (B)(6), WHO WAS ENROLLED IN (B)(6). ALTHOUGH, THE INFORMATION REGARDING SUBJECT RANDOMIZATION WAS NOT REPORTED ON THE SAE REPORT FORM, IT WAS CONFIRMED THAT THE PATIENT WAS RANDOMIZED TO THERASPHERE® STUDY DEVICE GROUP. THE SUBJECT RECEIVED THERASPHERE® 107 GY TO THE RIGHT LOBE AND 121 GY AND 115 GY TO THE LEFT LOBE ON (B)(6) 2017. INFORMATION REGARDING TREATMENT WITH SECOND-LINE CHEMOTHERAPY FOR METASTATIC COLORECTAL CARCINOMA WAS NOT PROVIDED. THE SUBJECT'S MEDICAL HISTORY WAS NOT REPORTED AT THE TIME OF THIS REPORT. ON (B)(6) 2018, THE SUBJECT WAS HOSPITALIZED DUE TO GASTRIC PERFORATION, GRADE 3. THE SUBJECT TREATMENT WAS NOT REPORTED AT THE TIME OF THIS REPORT. THE EVENT GASTRIC PERFORATION OUTCOME WAS NOT REPORTED AT THE TIME OF THIS REPORT. THE SUBJECT CONTINUED PARTICIPATION IN THE STUDY. THE INVESTIGATOR ASSESSED THE EVENT OF GASTRIC PERFORATION AS GRADE-3 (SEVERE) IN INTENSITY, SERIOUS CRITERION WAS REPORTED AT THE TIME OF THIS REPORT. THE EVENT WAS ASSESSED AS POSSIBLY RELATED TO STUDY DEVICE (TO SELECTIV

  Patient problems: Internal Organ Perforation; No Known Impact Or Consequence To Patient

  MAUDE report 7288236 ↗