TheraSphere Y90 Glass Microspheres 7.5 GBq 990700.SPERecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05060116920406), received between Jun 16, 2017 and Jul 2, 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.

• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SUBJECT EXPERIENCED ANEMIA REQUIRING MEDICATION AS A RESULT OF THE THERASPHERE DEVICE OR PROCEDURE. THE SUBJECT WAS ENROLLED INTO THE STUDY ON (B)(6) 2024. PRE-TREATMENT MACROAGGREGATED ALBUMIN (MAA) IMAGING DOCUMENTED A SIGNIFICANTLY HIGHER PERFUSION OF MAA ON TUMORS. DOSE TO PERFUSED LIVER WAS 258 GY, AND LUNG SHUNT CALCULATION WAS 0%. ON (B)(6) 2025, THE TREATMENT WITH THERASPHERE WAS PERFORMED. THERASPHERE WAS ADMINISTERED TO THE LIVER THROUGH THE FEMORAL ARTERY VIA TWO DOSE VIALS. TOTAL ADMINISTERED ACTIVITY DOSE WAS 8.245 GBQ. POST-TREATMENT DOSIMETRY DOCUMENTED AVID UPTAKE IN ALL LESIONS OF Y-90 ON TUMORS. DOSE TO PERFUSED LIVER WAS 258 GY AND DOSE TO TOTAL NORMAL TISSUE WAS 82 GY. LUNG DOSE CALCULATION WAS 0. ON (B)(6) 2025, FIVE DAYS FOLLOWING THERASPHERE ADMINISTRATION, THE SUBJECT WAS NOTED WITH ANEMIA, LYMPHOPENIA, AND ASPARTATE AMINOTRANSFERASE (ASAT) INCREASE. THE ANEMIA WAS MEDICALLY TREATED WITH SPECIAFOLDINE (5 MG/ORAL/DAILY). NO ACTION WAS TAKEN TO TREAT THE LYMPHOPENIA AND INCREASED ASAT LEVELS. ON (B)(6) 2025, THE LYMPHOPENIA AND INCREASED ASAT LEVELS WERE RESOLVED. ON (B)(6) 2025, THE ANEMIA WAS RESOLVED.

  Patient problems: Anemia; Liver Damage/Dysfunction; Low White Blood Cell Count; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22387087 ↗
• DeathJul 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4). (B)(5). INITIAL SAE REPORT: (B)(6) 2017. SAE: GASTRIC ISCHEMIA (INTESTINAL ISCHAEMIA) THIS SAE IS LINKED WITH UNPLANNED INFUSION OF THE TOTAL LIVER, GASTRIC, DUODENAL AND PANCREATIC BECAUSE THE CATHETER MOVED (PROBABLY DUE TO A MOVEMENT OF THE PATIENT), SAE: HYPERTHYROIDIA, CAPTURED UNDER (B)(4) AND SAE: ACUTE PANCREATITIS, CAPTURED UNDER (B)(4) (EMDR MFR# 3002124543-2017-00030). THIS REPORT CONCERNS SUBJECT (B)(6) MALE PATIENT BORN IN (B)(6) WHO WAS ENROLLED IN STUDY (B)(6)ENTITLED "A PHASE III CLINICAL TRIAL OF INTRA-ARTERIAL THERASPHERE® IN THE TREATMENT OF PATIENTS WITH UNRESPECTABLE HEPATOCELLULAR CARCINOMA (HCC). ON (B)(6) 2016, THE SUBJECT RECEIVED TREATMENT WITH STUDY DEVICE THERASPHERE® TOTAL 67.5 GY FOR HEPATOCELLULAR CARCINOMA IN BOTH THE LOBES (ADMINISTRATION OF THE DOSE LOWER THAN REQUIRED BY PROTOCOL IS ASSOCIATED WITH CASE CAPTURED UNDER (B)(4)). ON (B)(6) 2017, THE SUBJECT COMMENCED TREATMENT WITH STANDARD OF CARE THERAPY (SORAFENIB) AT 400 MG PO BID AND CONTINUED THIS DOSAGE TILL (B)(6) 2017. FROM (B)(6) 2017, STANDARD OF CARE THERAPY (SORAFENIB) 400 MG PO QD WAS GIVEN REASON OF REDUCTION WAS UNKNOWN. ON (B)(6) 2017, STANDARD OF CARE THERAPY (SORAFENIB) WAS

  Patient problems: No Code Available

  MAUDE report 6728283 ↗
• InjuryJun 16, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MFR REPORT NUMBER: 3002124543-2017-00030. INTERNAL MCN: 2017M5000117. SUBJECT# 0417-004. LAST SAE REPORT: 24 MAY 2016. SAE: ACUTE PANCREATITIS (PANCREATITIS ACUTE). THIS SAE IS LINKED WITH UNPLANNED INFUSION OF THE TOTAL LIVER, GASTRIC, DUODENAL AND PANCREATIC BECAUSE THE CATHETER MOVED (PROBABLY DUE TO A MOVEMENT OF THE PATIENT) AND SAE: HYPERTHYROIDIA, CAPTURED UNDER MCN# 2017M5000112. THIS REPORT CONCERNS SUBJECT 0417-004, A (B)(6) PERSON WHO WAS ENROLLED IN STUDY (B)(6). ON (B)(6) 2016, THE SUBJECT RECEIVED TREATMENT WITH STUDY DEVICE THERASPHERE® TOTAL 67.5 GY FOR HEPATOCELLULAR CARCINOMA IN BOTH THE LOBES (ADMINISTRATION OF THE DOSE LOWER THAN REQUIRED BY PROTOCOL IS ASSOCIATED WITH DEVICE DEFICIENCY REPORTED UNDER MCN# 2017M500071). ON (B)(6)2017, THE SUBJECT COMMENCED TREATMENT WITH STANDARD OF CARE THERAPY (SORAFENIB) AT 400 MG PO BID AND CONTINUED THIS DOSAGE TILL(B)(6) 2017. FROM (B)(6)2017 TO (B)(6) 2017, STANDARD OF CARE THERAPY (SORAFENIB) 400 MG PO QD WAS GIVEN REASON OF REDUCTION IS UNKNOWN. ON (B)(6) 2017, STANDARD OF CARE THERAPY (SORAFENIB) WAS TEMPORARILY DISCONTINUED DUE TO FATIGUE. NO RELEVANT MEDICAL HISTORY WAS REPORTED EXCEPT FOR A TEMPORARY LIPASE INCREASE

  Patient problems: No Code Available

  MAUDE report 6646543 ↗