TheraSphere Y90 Glass Microspheres 20 GBq 990700.SPERecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05060116920338), received between Feb 22, 2018 and Dec 8, 2023 — classified as 3 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.

• InjuryDec 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROACTIF CLINICAL STUDY IT WAS REPORTED THE PATIENT EXPERIENCED ASTHENIA. ADVANCED, MULTICOMPARTMENT DOSIMETRY WAS PERFORMED TO ASSESS TREATMENT DOSE. PRE-TREATMENT MACROAGGREGATED ALBUMIN (MAA) DOSIMETRY DOCUMENTED, DOSE TO TOTAL PERFUSED LIVER WAS 240.1 GY AND DOSE TO TOTAL PERFUSED TUMOR WAS 387.4 GY. ON (B)(6) 2023 THE SUBJECT WAS ENROLLED INTO THE PROACTIF STUDY AND THE TREATMENT WITH THERASPHERE WAS PERFORMED ON THE SAME DAY. THE TYPE OF THERASPHERE INFUSION WAS LEFT LIVER. THE CATHETER WAS POSITIONED IN THE SEGMENTS II, III, IVA, IVB; 7.639 GBQ OF THERASPHERE WAS ADMINISTERED TO THE LEFT LIVER THROUGH VIAL 1. ON (B)(6) 2023, 25 DAYS POST INDEX PROCEDURE, THE SUBJECT EXPERIENCED ASTHENIA, ANOREXIA AND RIGHT ABDOMINAL PAIN. THE SUBJECT WAS HOSPITALIZED ON THE SAME DAY FOR TREATMENT AND EVALUATION. ABDOMINAL CT SCAN REVEALED TUMOR PROGRESSION, OCCURRENCE OF A LEFT PORTAL BRANCH THROMBOSIS AND PERI HEPATIC RIM OF ASCITES. LAB RESULTS REVEALED 50 MICROMOLE PER LITER OF TOTAL BILIRUBIN WHICH WAS EXPECTED TO BE NORMALIZED BY (B)(6) 2023. THE EVENT WAS TREATED WITH CONCOMITANT MEDICATION. THE CONDITION OF THE SUBJECT IMPROVED BY TREATING THE EVENTS ASTHENIA, ANOREXIA, AND ABDOMINAL

  Patient problems: Muscle Weakness/Atrophy

  MAUDE report 18292624 ↗
• InjuryFeb 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (RELATED TO MFR # 3002124543-2018-00008 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 (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) 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 AND ON (B)(6) 2016, THE

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

  MAUDE report 7288279 ↗
• InjuryFeb 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INTERNAL MCN # (B)(4). SUBJECT NUMBER: (B)(6). LAST SAE REPORT: 01 FEB 2018. SAE: GASTRIC PERFORATION (GASTRIC PERFORATION). THIS REPORT CONCERNS SUBJECT (B)(6), A FEMALE SUBJECT BORN IN (B)(6), WHO WAS ENROLLED IN STUDY (B)(4) ENTITLED "A PHASE III CLINICAL TRIAL EVALUATING THERASPHERE® IN SUBJECTS WITH METASTATIC COLORECTAL CARCINOMA OF THE LIVER WHO HAVE FAILED FIRST LINE CHEMOTHERAPY". 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

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

  MAUDE report 7288216 ↗