TheraSphere Y90 Glass Microspheres 6.0 GBq (US Commercial) OTT-SPE-FP-700 (990700.SPE)Recalls & reported problems
Biocompatibles Uk Ltd · TheraSphere Yttrium-90 Glass Microspheres 6.0 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 05060116921434), received between Feb 25, 2025 and Feb 25, 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
- Decreased Appetite1
- Fatigue1
- Insufficient Information1
- 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 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 21463343 ↗
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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