TheraSphere Y90 Glass Microspheres 10.5 GBq 990700.SPERecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05060116920451), received between Aug 31, 2023 and Jan 26, 2024 — classified as 2 injuries, 1 malfunction.

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.

• MalfunctionJan 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS ENROLLED IN THE INVESTIGATOR-INITIATED STUDY, IMMUWHY. IT WAS REPORTED THAT THE PATIENT HAD PLEURAL EFFUSION. IMMUWHY IS A PHASE II STUDY OF IMMUNOTHERAPY WITH DURVALUMAB, OR DURVALUMAB AND TREMELIMUMAB BOTH, COMBINED WITH Y-90 SIRT THERAPY IN PATIENTS WITH ADVANCED STAGE INTRAHEPATIC BILIARY TRACT CANCER (BTC) AND ARE SCHEDULED TO RECEIVE Y-90 SIRT THERAPY AS STANDARD OF CARE. THIS PATIENT RECEIVED DURVALUMAB AND UNDERWENT SIRT WITH THERASPHERE ADMINISTRATION ON (B)(6) 2023. ON (B)(6) 2024 THE PATIENT HAD PLEURAL EFFUSION AND WAS HOSPITALIZED. A PLEURAL PUNCTURE WAS PERFORMED. THE PATIENT WILL BE TRANSFERRED TO ANOTHER HOSPITAL FOR FURTHER TREATMENT AND SURGERY. IT WAS FURTHER REPORTED THAT THE PLEURAL EFFUSION WAS RESOLVED WITH SEQUELAE ON (B)(6) 2024; HOWEVER, THE EVENT OF PLEURAL EFFUSION WAS ASSESSED AS UNRELATED TO THE THERASPHERE DEVICE AND UNRELATED TO THE PROCEDURE PER THE INVESTIGATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pleural Effusion

  MAUDE report 18591404 ↗
• InjuryDec 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS ENROLLED IN THE INVESTIGATOR INITIATED STUDY, IMMUWHY. IT WAS REPORTED THAT THE PATIENT HAD ASCITES REQUIRING HOSPITALIZATION POST THERASPHERE PROCEDURE. IMMUWHY IS A PHASE II STUDY OF IMMUNOTHERAPY WITH DURVALUMAB OR DURVALUMAB AND TREMELIMUMAB, BOTH COMBINED WITH Y-90 SIRT THERAPY. THE PATIENTS HAVE ADVANCED STAGE INTRAHEPATIC BILIARY TRACT CANCER (BTC) AND ARE SCHEDULED TO RECEIVE Y-90 SIRT THERAPY AS STANDARD OF CARE. THIS PATIENT UNDERWENT SIRT WITH THERASPHERE ADMINISTRATION ON (B)(6) 2023. ON (B)(6) DURVALUMAB AND TREMELIMUMAB WERE GIVEN. ON (B)(6) 2023, THE PATIENT HAD ASCITES AND WAS HOSPITALIZED. THE PATIENT WAS SYMPTOMATIC WITH MEDICAL INTERVENTION INDICATED; THE DRAINAGE WAS CHANGED. THE PATIENT WAS DISCHARGED ON (B)(6) 2023, AND THE EVENT WAS CONSIDERED RESOLVED.

  Patient problems: Ascites

  MAUDE report 18320684 ↗
• InjuryAug 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS ENROLLED IN THE INVESTIGATOR INITIATED STUDY, IMMUWHY. IT WAS REPORTED THAT THE PATIENT HAD ESOPHAGEAL VARICES HEMORRHAGE AFTER SELECTIVE INTERNAL RADIATION THERAPY (SIRT). IMMUWHY IS A PHASE II STUDY OF IMMUNOTHERAPY WITH DURVALUMAB AND TREMELIMUMAB COMBINED WITH Y-90 SIRT THERAPY. THE PATIENTS HAVE ADVANCED STAGE INTRAHEPATIC BILIARY TRACT CANCER (BTC) AND ARE SCHEDULED TO RECEIVE Y-90 SIRT THERAPY AS STANDARD OF CARE. THIS PATIENT UNDERWENT SIRT WITH 5GBQ THERASPHERE ADMINISTRATION ON (B)(6) 2023. ON(B)(6) 2023, 1500 MG OF DURVALUMAB AND 3000 MG OF TREMELIMUMAB WERE GIVEN. ON (B)(6) 2023, THE PATIENT HAD ESOPHAGEAL VARICES HEMORRHAGE AND WAS HOSPITALIZED. A BLOOD TRANSFUSION WAS PERFORMED. IT WAS FURTHER REPORTED THAT THE PATIENT WAS DISCHARGED ON (B)(6) 2023, AND THE EVENT WAS CONSIDERED RESOLVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17660432 ↗