TheraSphere Y90 Glass Microspheres 7.5 GBq (US Commercial) OTT-SPE-FP-700 (990700.SPE)Recalls & reported problems
Biocompatibles Uk Ltd · TheraSphere Yttrium-90 Glass Microspheres 7.5 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 05060116921465), received between Apr 8, 2024 and Apr 8, 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
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN ALLERGIC REACTION OCCURRED POST-THERASPHERE ADMINISTRATION. THE PATIENT WAS TREATED WITH THERASPHERE ON (B)(6) 2024, DELIVERED TO THE RIGHT HEPATIC. APPROXIMATELY A WEEK AFTER TREATMENT, THE PATIENT EXPERIENCED FULL BODY HIVES THAT WOULD LAST A FEW HOURS AND WOULD COME AND GO. IT WAS NOTED THAT THE PATIENT DID NOT HAVE ANY NON-TARGET RADIATION EXPOSURE OR SHUNTING TO TISSUES NEAR THE SKIN. THE PATIENT DID NOT HAVE ANY KNOWN ALLERGIES TO GLASS, METALS, CONTRAST, MEDICATIONS, OR PRODUCTS. THE PATIENT ALSO HAD NO CHANGE IN THEIR CURRENT CHEMO MEDICATION REGIMEN. TREATMENT FOR THE HIVES WAS CONSERVATIVE WITH BENADRYL AND PREDNISONE, AND THE SYMPTOMS HAD SIGNIFICANTLY SUBSIDED AT THE TIME OF THIS REPORT.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 19059701 ↗
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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