TheraSphere Y90 Glass Microspheres 8.5 GBq 990700.SPERecalls & reported problems
Biocompatibles Uk Ltd · TheraSphere Yttrium-90 Glass Microspheres 8.5 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 05060116920420), received between Aug 28, 2025 and Aug 28, 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
- High Blood Pressure/ Hypertension1
- Unintended Radiation Exposure1
- Vomiting1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED ABDOMINAL PAIN AND VOMITING REQUIRING PRESCRIPTION MEDICATION AS A RESULT OF THE THERASPHERE PROCEDURE. THE PATIENT WAS BEING TREATED FOR UVEAL MELANOMA. A THERASPHERE Y-90 (8.5 GBQ) DOSE VIAL WAS SELECTED FOR USE IN THE RADIOEMBOLIZATION PROCEDURE. THE MULTIFOCAL, SMALL LESIONS WERE LOCATED IN THE BILOBAR LIVER. THE TOTAL TUMOR VOLUME WAS APPROXIMATELY 7.4ML. THERE WAS NOTHING UNUSUAL OBSERVED DURING DEVICE PREPARATION OR THE THERASPHERE PROCEDURE. POST PROCEDURE IMAGING REVEALED THE EXPECTED ACCUMULATION OF MICROSPHERES WITHIN THE LIVER, AS WELL AS ACCUMULATION WITHIN THE AREA OF THE GALLBLADDER. FOLLOWING THE THERASPHERE PROCEDURE, THE PATIENT EXPERIENCED TRANSITORY UPPER ABDOMINAL PAIN, VOMITING, AND A HYPERTENSIVE CRISIS. TO TREAT THE PAIN AND VOMITING, THE PATIENT WAS ADMINISTERED NOVALGIN AND ODANSETRON (ZOFRAN). THE PATIENT WAS ALSO ADMINISTERED ANTIBIOTIC CHOLECYSTITIS PROPHYLAXIS WITH UNACID. THE PAIN WAS REPORTED TO HAVE RESOLVED AFTER ONE DAY. THERE WAS NO REPORTED INTERVENTION FOR THE HYPERTENSIVE CRISIS. THERE WERE NO FURTHER PATIENT COMPLICATIONS.
Patient problems: Abdominal Pain; High Blood Pressure/ Hypertension; Unintended Radiation Exposure; Vomiting
MAUDE report 22916931 ↗
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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