TheraSphere Y90 Glass Microspheres 11.0 GBq (US Commercial) OTT-SPE-FP-700 (990700.SPE)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05060116921533), received between Oct 18, 2024 and May 28, 2025 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD NAUSEA AND PAIN THAT REQUIRED PRESCRIPTION MEDICATION. THE SUBJECT WAS ENROLLED INTO A CLINICAL STUDY ON (B)(6) 2024, THE FIRST TREATMENT WITH THERASPHERE WAS PERFORMED. ON (B)(6) 2024, THE SECOND TREATMENT WITH THERASPHERE WAS PERFORMED. THERASPHERE WAS ADMINISTERED TO THE LIVER WAS SELECTIVE (=2 SEGMENTS IN THE PERFUSED VOLUME) THROUGH FEMORAL ARTERY AND ONE DOSE VIAL WAS ADMINISTERED; TOTAL ADMINISTERED ACTIVITY DOSE WAS 3.84 GBQ. POST TREATMENT DOSIMETRY DOCUMENTED BETWEEN RANDOM ACTIVITY DISTRIBUTION AND AVID UPTAKE IN TARGET LESION DISTRIBUTION OF Y90 ON TUMORS. ON (B)(6) 2025, ON THE SAME DAY POST SECOND THERASPHERE ADMINISTRATION, THE SUBJECT WAS NOTED WITH NAUSEA, DIARRHEA, PAIN IN THE GROIN, AND FATIGUE. THE NAUSEA WAS MEDICALLY TREATED WITH ONDANSETRON ODT (ZOFRAN-ODT) (4MG/ORAL/AS NEEDED, (B)(6) 2025). PAIN IN THE GROIN WAS MEDICALLY TREATED WITH KETOROLAC (TORADOL) (10MG/ORAL/AS NEEDED, FROM (B)(6) 2025). NO ACTION WAS TAKEN TO TREAT THE EVENTS OF DIARRHEA AND FATIGUE. ON (B)(6) 2025, SEVEN DAYS POST SECOND THERASPHERE ADMINISTRATION, THE SUBJECT WAS NOTED WITH ABDOMINAL PAIN. NO ACTION WAS TAKEN TO TREAT THIS EVENT. IT WAS FURTHER

  Patient problems: Abdominal Pain; Diarrhea; Fatigue; Nausea; Pain

  MAUDE report 22099672 ↗
• InjuryJan 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD ABDOMINAL PAIN REQUIRING PRESCRIPTION MEDICATION. THE SUBJECT WAS ENROLLED INTO THE ROWAN CLINICAL STUDY ON (B)(6) 2024. PRE-TREATMENT MACROAGGREGATED ALBUMIN (MAA) IMAGING DOCUMENTED A SIGNIFICANTLY HIGHER PERFUSION OF MAA ON TUMORS, DOSE TO PERFUSED LIVER, AND DOSE TO TOTAL. LUNG SHUNT CALCULATION WAS 7.02 %. ON (B)(6) 2024, THERASPHERE WAS ADMINISTERED. ON (B)(6) 2024, COMBINATION THERAPY WITH 1500 MG DURVALUMAB FOLLOWED BY 300 MG OF TREMELIMUMAB WERE ADMINISTERED INTRAVENOUSLY. ON (B)(6) 2024, THE SUBJECT WAS NOTED WITH FATIGUE AND CONSTIPATION. ON (B)(6) 2024, THE SUBJECT WAS NOTED WITH NAUSEA. NO ACTIONS WERE TAKEN TO TREAT THE EVENTS OF FATIGUE AND NAUSEA. THE EVENT OF CONSTIPATION WAS TREATED MEDICALLY WITH 8.6 MG SENNA TWICE DAILY/ORAL FROM (B)(6) 2024. ON (B)(6) 2024, THE SUBJECT WAS NOTED WITH FATIGUE; NO ACTION WAS TAKEN TO TREAT THE EVENT. ON (B)(6) 2024, THE SUBJECT WAS NOTED WITH RIGHT UPPER QUADRANT ABDOMINAL PAIN, WHICH WAS TREATED MEDICALLY WITH 5 MG OXYCODONE AS NEEDED/ORAL FROM (B)(6) 2024.

  Patient problems: Abdominal Pain; Constipation; Fatigue; Nausea

  MAUDE report 21212223 ↗
• 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 30-AUG-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 (B)(4). 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 20484083 ↗