TheraSphere Y90 Glass Microspheres 4.5 GBq 990700.SPERecalls & reported problems
Biocompatibles Uk Ltd · TheraSphere Yttrium-90 Glass Microspheres 4.5 GBq Dose · 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 05060116920369), received between May 7, 2019 and May 7, 2019 — 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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Death1
- Encephalopathy1
- Liver Damage/Dysfunction1
- Renal Failure1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathMay 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT IS A (B)(6) MALE WITH NUMEROUS COMORBID PROBLEMS WITH A NEW DIAGNOSIS OF (B)(6) AND HEPATOCELLULAR CARCINOMA. HE WAS FOUND TO HAVE ASSOCIATED PORTAL VEIN THROMBOSIS, AND VERY ADVANCED HEPATOCELLULAR CARCINOMA. FOLLOWING A DISCUSSION OF TREATMENT OPTIONS HE ELECTED TO PROCEED WITH THERASPHERE TREATMENT. HE UNDERWENT THE PRELIMINARY MAPPING STUDY AND WAS FOUND TO HAVE SIGNIFICANT NARROWING OF HIS CELIAC ARTERY REQUIRING ANGIOPLASTY. HIS VASCULAR ANATOMY WAS OTHERWISE FAVORABLE TO PROCEED. POST MAPPING HE HAD WORSENING OF HIS UPPER ABDOMINAL PAIN AND HICCUPS. THE TREATING PHYSICIAN MET WITH HIM AGAIN ON (B)(6) AND ON THE DAY OF THE PROCEDURE (B)(6) AND EACH TIME REVIEWED THE PROS AND CONS OF PROCEEDING. THE PATIENT VERY MUCH WANTED TO MOVE FORWARD WITH THE TREATMENT. THE THERASPHERE TREATMENT WAS DELIVERED AS PLANNED ON (B)(6) 2019 WITH NO IMMEDIATE COMPLICATIONS OR PROBLEMS. HE WAS ADMITTED FOR OBSERVATION AND ACTUALLY FELT BETTER THAN HE HAD FOR SOMETIME. HE WAS DISCHARGED ON (B)(6) 2019. AT HOME HE CONTINUED TO FEEL WELL. HE IS ON COUMADIN FOR FACTOR 5 LEIDEN DEFICIENCY AND HAD A ROUTINE INR PERFORMED ON (B)(6) 2019 WHICH RETURNED AT 12. HE WAS ADMITTED TO (B)(6) HOSPITAL A
Patient problems: Death; Encephalopathy; Liver Damage/Dysfunction; Renal Failure
MAUDE report 8586403 ↗
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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