TheraSphere Y90 Glass Microspheres 8.0 GBq (US Commercial) OTT-SPE-FP-700 (990700.SPE)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05060116921472), received between Apr 3, 2024 and Oct 29, 2025 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH A STOMACH ULCER AND REQUIRED ADDITIONAL INTERVENTION. THE PATIENT WAS TREATED WITH THERASPHERE ON (B)(6) 2025. IMAGING PERFORMED DURING AND AFTER THE THERASPHERE PROCEDURE DID NOT REVEAL EXTRAHEPATIC DEPOSITION OF THERASPHERE. ON (B)(6) 2025, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH A STOMACH ULCER. THE PATIENT HAD A NASO-JEJUNAL TUBE PLACED TO FEED AND A DRAIN IMPLANTED TO FISTULIZE TO THE LEFT LIVER. THE RELATIONSHIP BETWEEN THE ULCER AND THE THERASPHERE DEVICE OR PROCEDURE WAS UNKNOWN.

  Patient problems: Ulcer

  MAUDE report 23418142 ↗
• InjuryFeb 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA STUDY THAT THE SUBJECT EXPERIENCED NAUSEA AND ABDOMINAL PAIN REQUIRING PRESCRIPTION MEDICATION, HOSPITALIZATION, AND ADDITIONAL INTERVENTION. THE SUBJECT WAS ENROLLED IN THE STUDY ON (B)(6) 2024. PRE-TREATMENT MAA IMAGING DOCUMENTED A SIGNIFICANTLY HIGHER PERFUSION OF MAA ON TUMORS. LUNG SHUNT CALCULATION WAS 2 %. ON (B)(6) 2024, THE TREATMENT WITH THERASPHERE WAS PERFORMED. THERASPHERE WAS ADMINISTERED TO SELECTIVE THROUGH FEMORAL ARTERY. TWO DOSE VIALS WERE ADMINISTERED, ON (B)(6) 2024, THE SUBJECT EXPERIENCED AN INCREASE IN ASPARTATE AMINOTRANSFERASE AND CONSTIPATION. MIRALAX WAS ADMINISTERED TO TREAT THE CONSTIPATION. ON (B)(6) 2024, THE SUBJECT EXPERIENCED AN INCREASE IN GAMMA-GLUTAMYL TRANSFERASE (GGT), ALKALINE PHOSPHATASE, AND ALANINE AMINOTRANSFERASE (ALT). NO ACTION WAS TAKEN TO TREAT THE EVENTS. ON (B)(6) 2024, THE SUBJECT EXPERIENCED FATIGUE, ABDOMINAL PAIN, AND WEIGHT LOSS. TRAMADOL WAS ADMINISTERED TO TREAT THE ABDOMINAL PAIN. ON (B)(6) 2024, THE SUBJECT EXPERIENCED INTERMITTENT NAUSEA. ZOFRAN WAS ADMINISTERED TO TREAT THE NAUSEA. ON (B)(6) 2025, THE SUBJECT EXPERIENCED ANOREXIA AND DRY MOUTH. NO ACTION WAS TAKEN TO TREAT THE EVENTS. ON (B)(6) 2025

  Patient problems: Abdominal Pain; Constipation; Decreased Appetite; Fatigue; Insufficient Information; Liver Damage/Dysfunction; Nausea

  MAUDE report 21463330 ↗
• InjuryOct 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ROWAN CLINICAL STUDY. IT WAS REPORTED THAT THE SUBJECT EXPERIENCED PAIN REQUIRING DIAGNOSTIC INTERVENTION AND MEDICATION. THE SUBJECT WAS ENROLLED INTO THE ROWAN STUDY ON (B)(6) 2024. PRE-TREATMENT IMAGING DOCUMENTED AVID UPTAKE IN TARGET LESION; DOSE TO PERFUSED LIVER WAS 663.2 GY. DOSE TO TOTAL NORMAL TISSUE WAS 43.2 GY. LUNG SHUNT CALCULATION WAS 6.0 %. ON (B)(6) 2024, TREATMENT WITH THERASPHERE WAS PERFORMED. THERASPHERE WAS ADMINISTERED TO THE LIVER THROUGH THE FEMORAL ARTERY. THREE DOSE VIALS WERE ADMINISTERED. TOTAL ADMINISTERED ACTIVITY DOSE WAS 7.23 GBQ. POST TREATMENT DOSIMETRY DOCUMENTED AVID UPTAKE IN TARGET LESION DISTRIBUTION OF Y90 ON TUMORS. DOSE TO PERFUSED LIVER WAS 884 GY AND DOSE TO TOTAL NORMAL TISSUE WAS 57.4 GY. LUNG DOSE CALCULATION WAS 21.7 GY. ON THE SAME DAY, POST THERASPHERE ADMINISTRATION, THE SUBJECT BEGAN TO EXPERIENCE PAIN IN THE RIGHT HIP TO THE LOWER EXTREMITY. AFTER THE PROCEDURE, THE PI ORDERED A CHECK OF BLOOD FLOW AND STARTED THE PATIENT ON ASA 325 MG. THE SUBJECT WAS REFERRED FOR AN ARTERIAL EVALUATION. THE EVENT WAS TREATED THROUGH ADMINISTRATION OF OXYCODONE.

  Patient problems: Pain

  MAUDE report 20483700 ↗
• InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ROWAN CLINICAL STUDY. IT WAS REPORTED THAT THE PATIENT EXPERIENCED NAUSEA REQUIRING A PRESCRIPTION MEDICATION. THE SUBJECT WAS ENROLLED INTO ROWAN STUDY ON (B)(6) 2024. PRE-TREATMENT MACROAGGREGATED ALBUMIN (MAA) IMAGING [PRIOR TO 1ST THERASPHERE TREATMENT] DETAILS OF PERFUSION OF MAA ON TUMORS WAS NOT AVAILABLE, DOSE TO PERFUSED LIVER WAS 275.8 GY, AND DOSE TO TOTAL NORMAL TISSUE WAS 32.9 GY. LUNG SHUNT CALCULATION WAS 1.8%. ON (B)(6) 2024, THE TREATMENT WITH THERASPHERE WAS PERFORMED. THERASPHERE ADMINISTERED TO THE LIVER WAS SELECTIVE (<=2 SEGMENTS IN THE PERFUSED VOLUME), AND 1 DOSE VIAL WAS ADMINISTERED; TOTAL ADMINISTERED ACTIVITY DOSE IS 2.88 GBQ. POST TREATMENT DOSIMETRY DOCUMENTED AVID UPTAKE IN TARGET LESION DISTRIBUTION OF Y90 ON TUMORS. DOSE TO PERFUSED LIVER WAS 413 GY; DOSE TO TOTAL NORMAL TISSUE WAS 37.5 GY. LUNG DOSE CALCULATION WAS 2.6%. ON (B)(6) 2024, COMBINATION THERAPY WITH 1500 MG DURVALUMAB FOLLOWED BY 300 MG OF TREMELIMUMAB WERE ADMINISTERED INTRAVENOUSLY. ON (B)(6) 2024, 14 DAYS POST THE THERASPHERE ADMINISTRATION, THE SUBJECT PRESENTED WITH PAIN, NAUSEA, AND FATIGUE. THE SUBJECT WAS TREATED WITH ZOFRAN FOR NAUSEA. NO OTHER ACTIONS WERE TAKEN TO TREAT FATIG

  Patient problems: Fatigue; Nausea; Pain

  MAUDE report 19037693 ↗