TheraSphere Y90 Glass Microspheres 11.0 GBq 990700.SPERecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05060116920468), received between Mar 30, 2018 and Jun 26, 2019 — 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.

• InjuryJun 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS A FOLLOW-UP REPORT TO RETRACT EVENT OF BILIARY SEPSIS, CLINICAL COURSE OF THE EVENT DATED 31 MAY 2019 THROUGH 15 JUN 2019, TO UPDATE OUTCOME OF EVENT RADIATION INDUCED LIVER DISEASE (RILD). INTERNAL MCN# (B)(4). SUBJECT# (B)(6). INITIAL SAE REPORT(S): 25-JUL-2019. SAE: RADIATION INDUCED LIVER DISEASE (RILD) (MEDDRA PT: RADIATION HEPATITIS). ON (B)(6) 2019, THE SUBJECT WAS HOSPITALIZED FOR PTC AND METALLIC STENT INSERTION, WHICH WAS COMPLETED SUCCESSFULLY, AND CHOLANGIOGRAM SHOWED GOOD BILATERAL DRAINAGE. ON 01 JUN 2019, THE SUBJECT WAS DISCHARGED ON ORAL ANTIBIOTICS AND VITAMIN A AND D SUPPLEMENTS. ON (B)(6) 2019, THE SUBJECT WAS READMITTED WITH FEVER AND RIGORS FOLLOWING PTC AND STENT PLACEMENT. BLOOD TEST SHOWED ELEVATED WHITE CELL COUNT AT 35 (PREVIOUSLY WAS AROUND 22) AND DERANGED LFTS (STATED AS LIKE PREVIOUS RESULTS). THE SUBJECT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS. ON AN UNKNOWN DATE, WHITE CELL COUNT FELL TO PRE-ADMISSION LEVEL. ON (B)(6) 2019, THE SUBJECT WAS DISCHARGED CLINICALLY WELL AND WITH CONSERVATIVE MANAGEMENT OF INFECTION. THE SUBJECT DIED ON (B)(6) 2019. CAUSE OF DEATH PER DEATH CERTIFICATE WAS BILIARY SEPSIS, METASTATIC DESCENDING COLON CANCER. PER

  Patient problems: Death; Hyperbilirubinemia; Liver Damage/Dysfunction; Sepsis

  MAUDE report 8734292 ↗
• 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 # 3002124543-2018-00019. INTERNAL MCN: (B)(4). SUBJECT NUMBER: (B)(6). LAST SAE REPORT: (B)(6) 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# 3002124543-2018-00018 FOR ANOTHER DEVICE ASSOCIATED WITH THIS EVENT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL RELEVANT INFORMATION IS RECEI

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

  MAUDE report 7384590 ↗