TheraSphere Y90 Glass Microspheres 11.5 GBq (US Commercial) OTT-SPE-FP-700 (990700.SPE)Recalls & reported problems
Biocompatibles Uk Ltd · TheraSphere Yttrium-90 Glass Microspheres 11.5 GBq Dose (US Commercial) · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05060116921540), received between Dec 6, 2024 and Dec 6, 2024 — classified as 1 death.
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
- Ischemia Stroke1
- Loss of consciousness1
- Obstruction/Occlusion1
- Respiratory Insufficiency1
- Ventilator Dependent1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathDec 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A STROKE AND PASSED AWAY. THIS PATIENT WAS ENROLLED IN THE EMERALD Y-90 STUDY AND TREATED WITH THERASPHERE ON (B)(6) 2024. THE THERASPHERE TREATMENT WENT SMOOTHLY AND EXACTLY AS PLANNED VIA LEFT RADIAL ARTERY APPROACH. AFTER TREATMENT, THE SITE REMOVED THE CATHETERS AND PUT THE RADIAL BAND ON. DURING THIS PROCESS, THE PATIENT STARTED BREATHING ABNORMALLY AND BECAME UNRESPONSIVE. THE PATIENT WAS INTUBATED FOR AIRWAY PROTECTION AND TAKEN TO THE MEDICAL INTENSIVE CARE UNIT (ICU). COMPUTED TOMOGRAPHY (CT) WAS PERFORMED OF THE HEAD AND THE CHEST/ABDOMEN/PELVIS WITH NOTHING NOTABLE. MAGNETIC RESONANCE IMAGING (MRI) AND MAGNETIC RESONANCE ANGIOGRAPHY (MRA) OF THE HEAD REVEALED A BASILAR ARTERY OCCLUSION AND LARGE POSTERIOR CIRCULATION STROKE, THUS A THROMBECTOMY WAS PERFORMED SUCCESSFULLY. THE PATIENT'S PROGNOSIS WAS POOR AND CLINICALLY UNIMPROVED AFTER THE THROMBECTOMY. THE PATIENT WAS PLACED ON COMFORT CARE, BUT ULTIMATELY THE FAMILY MADE THE DECISION TO PLACE ON DO NOT RESUSCITATE / DO NOT INTUBATE (DNR/DNI) AND TERMINALLY EXTUBATED. THE PATIENT PASSED AWAY (B)(6) 2024.
Patient problems: Ischemia Stroke; Loss of consciousness; Obstruction/Occlusion; Respiratory Insufficiency; Ventilator Dependent
MAUDE report 20864517 ↗
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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