TheraSphere Y90 Glass Microspheres 20.0 GBq (US Commercial) OTT-SPE-FP-700 (990700.SPE)Recalls & reported problems
Biocompatibles Uk Ltd · TheraSphere Yttrium-90 Glass Microspheres 20.0 GBq Dose (US Commercial) · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05060116921717), received between Feb 18, 2025 and Feb 18, 2025 — classified as 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Abdominal Pain1
- Constipation1
- Fatigue1
- Liver Damage/Dysfunction1
- Nausea1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 18, 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 EXPERIENCED PAIN, NAUSEA, AND LIVER DYSFUNCTION, WHICH REQUIRED PRESCRIPTION MEDICATION. THE SUBJECT WAS ENROLLED INTO THE STUDY ON 12-DEC-2024. PRE-TREATMENT MACROAGGREGATED ALBUMIN (MAA) IMAGING DOCUMENTED A SIGNIFICANTLY HIGHER PERFUSION OF MAA ON TUMORS, AND DOSE TO PERFUSED LIVER WAS 405 GY. LUNG SHUNT CALCULATION WAS 9 %. ON (B)(6) 2024, THE TREATMENT WITH THERASPHERE WAS PERFORMED. THERASPHERE WAS ADMINISTERED TO THE LIVER SELECTIVE (<=2 SEGMENTS IN THE PERFUSED VOLUME) THROUGH FEMORAL ARTERY. ONE DOSE VIAL WAS ADMINISTERED. TOTAL ADMINISTERED ACTIVITY WAS 5.18 GBQ. POST TREATMENT DOSIMETRY DOCUMENTED AVID UPTAKE IN TARGET LESION. DOSE TO PERFUSED LIVER WAS 387.9 GY. LUNG DOSE CALCULATION WAS 23.4. ON (B)(6) 2025, COMBINATION THERAPY WITH 1500 MG DURVALUMAB FOLLOWED BY 300 MG OF TREMELIMUMAB WERE ADMINISTERED INTRAVENOUSLY. ON (B)(6) 2025, MONOTHERAPY OF 1500 MG DURVALUMAB WAS ADMINISTERED INTRAVENOUSLY. ON (B)(6) 2024, SAME DAY OF THERASPHERE ADMINISTRATION, THE SUBJECT EXPERIENCED NAUSEA AND RIGHT UPPER QUADRANT ABDOMINAL PAIN. THE SUBJECT WAS TREATED FOR THE NAUSEA WITH ZOFRAN (40.25 MG/ AS NEEDED) AND FOR THE ABDOMINAL
Patient problems: Abdominal Pain; Constipation; Fatigue; Liver Damage/Dysfunction; Nausea
MAUDE report 21397860 ↗
Other Microspheres Radionuclide devices
- TheraSphere Administration Set OTT-SPE-FP-001Biocompatibles Uk Ltd · Microspheres Radionuclide2 recalls2 reports
- TheraSphere Administration Set 990226.SPEBiocompatibles Uk Ltd · Microspheres Radionuclide1 recall3 reports
- TheraSphere Y90 Glass Microspheres 3 GBq 990700.SPEBiocompatibles Uk Ltd · Microspheres Radionuclide5 deaths19 reports
- TheraSphere Y90 Glass Microspheres 3.0 GBq (US Commercial) OTT-SPE-FP-700 (990700.SPE)Biocompatibles Uk Ltd · Microspheres Radionuclide13 reports
- SIR-Spheres microspheres SIR-Y001Sirtex Medical Inc. · Microspheres Radionuclide4 deaths11 reports
- TheraSphere Y90 Glass Microspheres 5 GBq 990700.SPEBiocompatibles Uk Ltd · Microspheres Radionuclide1 death8 reports
- TheraSphere Y90 Glass Microspheres 4.0 GBq 990700.SPEBiocompatibles Uk Ltd · Microspheres Radionuclide2 deaths7 reports
- TheraSphere Y90 Glass Microspheres 3.5 GBq 990700.SPEBiocompatibles Uk Ltd · Microspheres Radionuclide1 death6 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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