TheraSphere Y90 Glass Microspheres 18.5 GBq (US Commercial) OTT-SPE-FP-700 (990700.SPE)Recalls & reported problems
Biocompatibles Uk Ltd · TheraSphere Yttrium-90 Glass Microspheres 18.5 GBq Dose (US Commercial) · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 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 05060116921687), received between Oct 18, 2024 and Oct 18, 2024 — 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
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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 (B)(6) 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 20484074 ↗
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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