TheraSphere Y90 Glass Microspheres 8.0 GBq 990700.SPERecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05060116920413), received between Jul 28, 2017 and Dec 28, 2018 — classified as 2 deaths.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathDec 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS A FOLLOW-UP REPORT TO UPDATE SUBJECT WEIGHT, CAUSE OF DEATH, STUDY DEVICE HEPATIC SEGMENTS TREATED, STUDY TREATMENT INFORMATION, PRINCIPAL INVESTIGATOR'S STATEMENT REGARDING CAUSALITY AND THE COMPANY ASSESSMENT. 2 THERASPHERE® VIALS WERE USED TO TREAT THIS PATIENT, IT CANNOT BE DETERMINED WHICH DEVICE CONTRIBUTED TO THE DEATH OF THE PATIENT. REFER TO MFR# 3002124543-2018-00053 FOR ANOTHER DEVICE ASSOCIATED WITH THIS EVENT. MFR # 3002124543-2018-00054. INTERNAL MCN: (B)(4). SUBJECT NUMBER: (B)(6). LAST SAE REPORT: 08 JAN 2019. SAE: DEATH. ON (B)(6) 2017, SEGMENT IV OF THE RIGHT HEPATIC LOBE WAS TREATED WITH THE STUDY DEVICE THERASPHERE®. ON (B)(6) 2017, SEGMENTS II AND III WERE TREATED WITH THE STUDY DEVICE THERASPHERE®. THE INVESTIGATOR CONFIRMED THAT THE CAUSE OF DEATH WAS UNKNOWN. TREATMENT WITH STUDY DRUG SORAFENIB WAS STARTED ON (B)(6) 2017 WITH A DOSE OF 200 MG, BID, AND ON (B)(6) 2018 SORAFENIB WAS DISCONTINUED DUE TO UNKNOWN REASONS. THE INVESTIGATOR STATED THAT WHILE IT WAS EXTREMELY UNLIKELY THAT THERE WAS A RELATIONSHIP BETWEEN THE SUBJECT'S DEATH AND THE STUDY DEVICE, PROCEDURE OR SORAFENIB TREATMENT, WITHOUT ACCOMPANYING INFORMATION FROM THE SUBJECT'S CARE PROVI

  Patient problems: Death; No Code Available

  MAUDE report 8202099 ↗
• DeathJul 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4). SUBJECT NUMBER: (B)(6). LAST SAE REPORT: (B)(6) 2017. SAE: LIVER DECOMPENSATION (HEPATIC FAILURE) THIS REPORT CONCERNS SUBJECT (B)(6) MALE WHO WAS ENROLLED IN STUDY (B)(6) ENTITLED "A PHASE III CLINICAL TRIAL OF INTRA-ARTERIAL THERASPHERE® IN THE TREATMENT OF PATIENTS WITH UNRESECTABLE HEPATOCELLULAR CARCINOMA (HCC). THE SUBJECT RECEIVED TREATMENT WITH STUDY DEVICE THERASPHERE® 128 GY TO THE RIGHT LOBE ON (B)(6) 2017 AND 120 GY TO THE LEFT HEPATIC LOBE ON (B)(6) 2017 FOR HEPATOCELLULAR CARCINOMA. AT THE TIME OF THIS EVENT, TREATMENT WITH STANDARD OF CARE THERAPY (SORAFENIB) WAS NOT INITIATED FOR THE SUBJECT. THE SUBJECT'S PAST MEDICAL HISTORY INCLUDED APPENDICITIS, PETROUS BONE FRACTURE, COMA, (B)(6), MENISCUS INJURY, MENISCECTOMY, ONGOING MEDICAL HISTORY INCLUDED HIGH BLOOD PRESSURE, DEPRESSIVE SYNDROME, PRURITUS AND ICTERUS. CONCOMITANT MEDICATIONS INCLUDED CITALOPRAM, VALSARTAN AND ATARAX. ON (B)(6) 2017 RESPECTIVELY, PRIOR TO HOSPITALIZATION, THE SUBJECT'S BILIRUBIN LEVELS WERE 55 MMOL/L, 143 MICROMOL/L (NORMAL RANGE: 3-17 MICROMOL/L). THE SUBJECT HAD ICTERUS AND INCREASED ABDOMINAL PERIMETER AND HENCE WAS HOSPITALIZED FOR ASCITIC PUNCTURE ON (B)(6) 2017. 5.5 LITERS OF

  Patient problems: Liver Damage/Dysfunction

  MAUDE report 6750391 ↗