TheraSphere Y90 Glass Microspheres 14.0 GBq 990700.SPERecalls & reported problems
Biocompatibles Uk Ltd · TheraSphere Yttrium-90 Glass Microspheres 14.0 GBq Dose · 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 05060116920529), received between Jul 2, 2025 and Jul 2, 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
- Anemia1
- Liver Damage/Dysfunction1
- Low White Blood Cell Count1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE SUBJECT EXPERIENCED ANEMIA REQUIRING MEDICATION AS A RESULT OF THE THERASPHERE DEVICE OR PROCEDURE. THE SUBJECT WAS ENROLLED INTO THE STUDY ON (B)(6) 2024. PRE-TREATMENT MACROAGGREGATED ALBUMIN (MAA) IMAGING DOCUMENTED A SIGNIFICANTLY HIGHER PERFUSION OF MAA ON TUMORS. DOSE TO PERFUSED LIVER WAS 258 GY, AND LUNG SHUNT CALCULATION WAS 0%. ON (B)(6) 2025, THE TREATMENT WITH THERASPHERE WAS PERFORMED. THERASPHERE WAS ADMINISTERED TO THE LIVER THROUGH THE FEMORAL ARTERY VIA TWO DOSE VIALS. TOTAL ADMINISTERED ACTIVITY DOSE WAS 8.245 GBQ. POST-TREATMENT DOSIMETRY DOCUMENTED AVID UPTAKE IN ALL LESIONS OF Y-90 ON TUMORS. DOSE TO PERFUSED LIVER WAS 258 GY AND DOSE TO TOTAL NORMAL TISSUE WAS 82 GY. LUNG DOSE CALCULATION WAS 0. ON (B)(6) 2025, FIVE DAYS FOLLOWING THERASPHERE ADMINISTRATION, THE SUBJECT WAS NOTED WITH ANEMIA, LYMPHOPENIA, AND ASPARTATE AMINOTRANSFERASE (ASAT) INCREASE. THE ANEMIA WAS MEDICALLY TREATED WITH SPECIAFOLDINE (5 MG/ORAL/DAILY). NO ACTION WAS TAKEN TO TREAT THE LYMPHOPENIA AND INCREASED ASAT LEVELS. ON (B)(6) 2025, THE LYMPHOPENIA AND INCREASED ASAT LEVELS WERE RESOLVED. ON (B)(6) 2025, THE ANEMIA WAS RESOLVED.
Patient problems: Anemia; Liver Damage/Dysfunction; Low White Blood Cell Count; No Clinical Signs, Symptoms or Conditions
MAUDE report 22387089 ↗
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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