TheraSphere Y90 Glass Microspheres 9.0 GBq 990700.SPERecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05060116920437), received between Mar 30, 2018 and Feb 26, 2025 — classified as 1 death, 1 injury.

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.

• InjuryFeb 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT HAD ASCITES, REQUIRING INTERVENTION. PRIOR TO TREATMENT, ADVANCED, MULTICOMPARTMENT DOSIMETRY WAS PERFORMED TO ASSESS TREATMENT DOSE. VASCULAR ACCESS WAS OBTAINED THROUGH THE FEMORAL ARTERY. 99MTC-MACROAGGREGATED ALBUMIN (MAA) INFUSION WAS PERFORMED DURING THE PRE-TREATMENT ANGIOGRAPHY. CATHETER POSITION FOR THE 99MTC-MAA INFUSION WAS RIGHT HEPATIC ARTERY (IRRESPECTIVE OF ORIGIN) (SEGMENTS V/VI/VII/VIII). SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY (SPECT / CT) WAS PERFORMED AS A POST 99MTC-MAA 3D IMAGING WHICH REVEALED SIGNIFICANTLY HIGHER OVERALL PERFUSION IN TUMOUR VERSUS NORMAL LIVER AND INTERMEDIATE DISTRIBUTION (99MTC-MAA DISTRIBUTION IN 50 - < 98% OF THE TUMOUR VOLUME). 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 RIGHT LIVER. THE CATHETER WAS POSITIONED AT RIGHT HEPATIC ARTERY (IRRESPECTIVE OF ORIGIN) (SEGMENTS V/VI/VII/VIII). 4.756 GBQ WAS ADMINISTERED TO THE RIGHT LIVER THROUGH VIAL 1. ON (B)(6) 2023, 108 DAYS POST INDEX PROCEDURE, THE SUBJECTED WAS DIAGNOSED WITH ASCITES. THIS EVENT RESULTED IN A PERMANE

  Patient problems: Ascites; Liver Damage/Dysfunction

  MAUDE report 21472727 ↗
• DeathMar 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS A FOLLOW-UP REPORT TO UPDATE THE STUDY DEVICE DOSING, CHEMOTHERAPY TREATMENT INFORMATION AND THE INVESTIGATOR'S ASSESSMENT. CONCLUSION CODES HAVE BEEN ACCORDINGLY UPDATED. MFR # 3002124543-2018-00018. (B)(4). (B)(6). LAST SAE REPORT: 19 JUL 2018. SAE: HEPATIC INSUFFICIENCY (HEPATIC FAILURE); HEMATEMESIS (HAEMATEMESIS); ACUTE KIDNEY FAILURE (ACUTE KIDNEY INJURY); ENCEPHALOPATHY (ENCEPHALOPATHY). THE DOSAGE OF THERASPHERE® THAT WAS ADMINISTERED ON (B)(6) 2017, TO THE RIGHT LOBE HAS BEEN CORRECTED TO 110 GY IN THIS FOLLOW UP REPORT, ALSO THE INVESTIGATOR ASSESSED THE EVENT OF HEPATIC INSUFFICIENCY AS POSSIBLY RELATED TO STUDY DEVICE AND ALSO POSSIBLY RELATED TO ALL OF THE STUDY PROCEDURE (RADIOEMBOLIZATION) PLUS CHEMOTHERAPY WITH THE STANDARD OF CARE THERAPY (SORAFENIB) AND TO PRE-EXISTING CONDITION. THE EVENT WAS CONSIDERED AS RELATED TO DISEASE UNDER STUDY. TWO THERASPHERE® VIALS WERE USED TO TREAT THIS PATIENT, IT CANNOT BE DETERMINED WHICH DEVICE CONTRIBUTED TO THE SERIOUS INJURY. REFER TO MDR# 3002124543-2018-00019 FOR ANOTHER DEVICE ASSOCIATED WITH THIS EVENT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED.

  Patient problems: Blood Loss; Death; Encephalopathy; Liver Damage/Dysfunction; Renal Failure

  MAUDE report 7384589 ↗