TheraSphere Y90 Glass Microspheres 16.5 GBq 990700.SPERecalls & reported problems
Biocompatibles Uk Ltd · TheraSphere Yttrium-90 Glass Microspheres 16.5 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 05060116920567), received between Aug 28, 2018 and Aug 28, 2018 — 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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Liver Damage/Dysfunction1
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS IS A FOLLOW-UP REPORT TO CORRECT THE EVENT VERBATIM, RESOLUTION DATE, OUTCOME, COMPANY ASSESSMENT, LABORATORY DATA AND EVENT PROBLEM AND EVALUATION CODES. INTERNAL MCN: (B)(4). SUBJECT # (B)(6). LAST SAE REPORT: 24 AUG 2018. SAE: LIVER FAILURE. THE EVENT VERBATIM WAS CHANGED FROM RAISED INR. RISEN ACUTELY FROM 1.2 ON 22/7/2018 TO 2.2 ON 31/7/2018 TO LIVER FAILURE. THE EVENT RESOLUTION DATE WAS REPORTED AS (B)(6) 2018. THE REPORTED OUTCOME WAS UPDATED TO RECOVERED/RESOLVED. THE COMPANY ASSESSED THE EVENT LIVER FAILURE AS PROBABLY RELATED TO STUDY DEVICE AND STUDY PROCEDURE. THE EVENT WAS ASSESSED AS POSSIBLY RELATED TO SECOND LINE CHEMOTHERAPY AND DISEASE UNDER STUDY. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL RELEVANT INFORMATION IS RECEIVED.
Patient problems: Liver Damage/Dysfunction; No Code Available
MAUDE report 7821883 ↗
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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