Microspheres Radionuclide
FDA adverse event reports and recall history for microspheres radionuclide (product code NAW), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 576
- Deaths
- 142
- Injuries
- 363
- Malfunctions
- 25
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2021-08-19Open, ClassifiedComponent change control
TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)
Potential for leaks and loosening at the patient catheter connection
- 2021-08-19Open, ClassifiedComponent change control
TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)
Potential for leaks and loosening at the patient catheter connection
- 2013-04-23TerminatedLabeling False and Misleading
Sirtex SIR-yttrium 90 microspheres (Radionuclide); SIR-Y001. Indicated for the treatment of unresectable metastatic liver tumors.
Incorrect expiration date
- 2009-06-05TerminatedError in labeling
TheraSphere Administration Set (Part Number K125914-034). TheraSphere is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable Hepatocellular carcinoma(HCC) who can have placement of appropriately positioned hepatic arterial catheters. The device is also indicated for HCC patients with partial or branch portal vein thrombosis/occlusion.
Instructions for the use of the pinch clamp that is an integral part of the TheraSphere Administration Set were not included with the distribution of the device.
- TerminatedPackaging
TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable HCC who can have placement of appropriately positioned hepatic arterial catheters.
One mislabeled dose of TheraSphere Y-90 Glass Microspheres, which was shipped to Hong Kong (total radioactivity incorrect). The product ws labeled as 10 GBq and the actual does was 5 GBq.
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