TheraSphere Y90 Glass Microspheres 9.5 GBq 990700.SPERecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05060116920444), received between Apr 26, 2023 and Dec 15, 2023 — classified as 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT WAS HOSPITALIZED FOR TREATMENT OF ASCITES. ON (B)(6) 2022, THE SUBJECT WAS ENROLLED INTO THE PROACTIF STUDY AND THE TREATMENT WITH THERASPHERE TO THE RIGHT LIVER WAS PERFORMED ON THE SAME DAY. THE CATHETER WAS POSITIONED IN THE RIGHT HEPATIC ARTERY (IRRESPECTIVE OF ORIGIN) (SEGMENTS V/VI/VII/VIII), AND 3.55 GBQ OF THERASPHERE WAS ADMINISTERED THROUGH VIAL 1. THE DOSE TO TOTAL PERFUSED TUMOR WAS 213.4 GY. ON AN UNKNOWN DATE IN (B)(6) 2022, THE SUBJECT WAS DIAGNOSED WITH ASCITIC DECOMPENSATION. THE SUBJECT WAS HOSPITALIZED AND TREATED WITH FUROSEMIDE 60 AND ALDACTONE 100. THE PATIENT HAD BEEN DISCHARGED FROM THE HOSPITAL AND THE ISSUE WAS CONSIDERED RESOLVED. THE PATIENT HAD BEEN DISCHARGED FROM THE HOSPITAL AND THE ISSUE WAS CONSIDERED RESOLVED.

  Patient problems: Ascites

  MAUDE report 18334260 ↗
• InjuryApr 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROACTIF CLINICAL STUDY. IT WAS REPORTED THAT THE PATIENT DEVELOPED A PERSISTENT FEVER REQUIRING HOSPITALIZATION. ADVANCED, MULTICOMPARTMENT DOSIMETRY WAS PERFORMED TO ASSESS THE TREATMENT DOSE. PER-TREATMENT TC-MAA (TECHNETIUM MACROAGGREGATED ALBUMIN) UPTAKE BY THE PERFUSED LIVER WAS 160 GY AND PERFUSED TUMOR WAS 190 GY. ON (B)(6) 2023, THE SUBJECT WAS ENROLLED INTO THE PROACTIF STUDY AND TREATMENT WITH THERASPHERE WAS PERFORMED ON THE SAME DAY. THE THERASPHERE INFUSION SITE WAS SELECTIVE. THE CATHETER WAS POSITIONED IN THE ACCESSORY RIGHT HEPATIC ARTERY (SEGMENTS VI/VII): 3.2 GBQ OF THERASPHERE WAS ADMINISTERED TO THE SELECTIVE LIVER THROUGH VIAL 1. POST TREATMENT DOSIMETRY DOCUMENTED A STRONG UPTAKE OF THE DELIVERED DOSE TO PERFUSED LIVER, WHICH WAS 151 GY AND TO THE PERFUSED TUMOR WAS 164 GY. ON (B)(6) 2023, 1 DAY POST INDEX PROCEDURE, THE SUBJECT DEVELOPED PERSISTENT FEVER. ON (B)(6) 2023, THE SUBJECT WAS ADMITTED TO THE HOSPITAL FOR FURTHER EVALUATION AND TREATMENT. FEVER DEVELOPED POST CHEMOTHERAPY AND RADIOEMBOLIZATION. THE SUBJECT WAS TREATED WITH CONCOMITANT MEDICATION. A CT SCAN REVEALED NO SIGN OF PERFORATION AND SURINFECTION (SECONDARY INFECTION); BLOOD CULTURE WAS STE

  Patient problems: Fever

  MAUDE report 16817439 ↗