SIR-Spheres Y-90 resin microspheres SIR-Y002Recalls & reported problems
Sirtex Medical Inc. · SIR-Y002 (1.8Gbq/3ml): SIR-Spheres Y-90 resin microspheres consist of biocompatible resin microspheres containing yttrium-90 with a size between 20 and 60 microns in diameter. Each vial contains 1.8 GBq of Y90 ± 10% (at the time of calibration) in a total of 3 cc water for injection. Yttrium-90 is a high-energy pure beta-emitting isotope with no primary gamma emission. The maximum energy of the beta particles is 2.27MeV with a mean of 0.93MeV. The maximum range of emissions in tissue is 11mm with a mean of 2.5mm. This is a brachytherapy product considered to be a sealed source device. The yttrium-90 has a purity specification of 999,900 ppm at reference, at (or after) time of manufacture of SIR-Spheres microspheres. The half-life is 64.1 hours. In use requiring the isotope to decay to infinity, 94% of the radiation is delivered in 11 days leaving only background radiation with no therapeutic value. SIR-Spheres microspheres themselves are a permanent implant. Each device is for single patient use. · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00850014612146), received between Jan 17, 2025 and Mar 24, 2026 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Contamination” (1 report).
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
- Contamination1
- Improper Flow or Infusion1
- Migration1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Pain2
- Gastritis1
- Nausea1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryMar 24, 2026No Apparent Adverse Event
THE PHYSICIAN CALLED STASIS AND ONLY 41% OF PRESCRIBED ACTIVITY DELIVERED THAT WAS DETERMINED USING POST RADIATION MEASUREMENTS BY THE NUC MED TECH. THE PROCTOR AT THE CASE DOES NOT BELIEVE THIS IS NOT ACCURATE AND BELIEVES THE PATIENT GOT THE FULL DOSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24675016 ↗InjuryAug 22, 2025Improper Flow or Infusion; Improper Flow or Infusion
PHYSICIAN REACHED STASIS UNEXPECTEDLY. THE PATIENT STAYED OVERNIGHT AND WAS IN SOME PAIN.
Patient problems: Pain
MAUDE report 22873954 ↗MalfunctionAug 14, 2025Contamination; Contamination
WHILE DRAWING DOSE IN HOT LAB, A SMALL PARTICLE WAS OBSERVED INSIDE THE VIAL. AFTER INVESTIGATING, IT WAS DETERMINED THAT A PIECE OF SEPTUM DETACHED AND WAS DISPLACED INTO THE VIAL. NO RESIDUE/PARTICLES WERE OBSERVED IN THE D-VIAL DOSES AND DRAW CONTINUED. PARTICLE OBSERVED INSIDE Y-90 VIAL DURING DRAW, WHICH WAS DETERMINED TO BE SEPTUM. NEEDLE MUST HAVE DETACHED A PORTION OF SEPTUM DURING DRAW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22805344 ↗InjuryJan 17, 2025Migration; Migration
POST PROCEDURE IMAGING SHOWED THAT A SIGNIFICANT PORTION OF THE TREATING DOSE WAS DELIVERED TO PATIENT'S SPLEEN AND STOMACH. PATIENT EXPERIENCED NAUSEA AND PAIN AFTER THE PROCEDURE. PATIENT IS DOING WELL NOW.
Patient problems: Gastritis; Nausea; Pain
MAUDE report 21183722 ↗
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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